System and method for percutaneous palate remodeling

ABSTRACT

Methods and devices are disclosed for manipulating the palatal tissue. An implant is positioned within at least a portion of the soft palate and may be secured to other surrounding, less mobile structures such as the hard palate or the mucosa overlying the hard palate. The implant may be manipulated to displace at least a portion of the soft palate in an anterior or lateral direction, or to alter the tissue tension or compliance of the soft palate.

INCORPORATION BY REFERENCE

This application a) claims priority under 35 U.S.C. §119(e) fromprovisional application Ser. No. 60/815,783 filed Jun. 21, 2006, and isalso b) a continuation-in-part of application Ser. No. 11/349,045 filedFeb. 7, 2006, which claims priority under 35 U.S.C. §119(e) fromprovisional application Ser. No. 60/650,867 filed Feb. 8, 2005 andprovisional application Ser. No. 60/726,028 filed Oct. 12, 2005, all ofthe disclosures of which are herein incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to a system and method for treatingupper airway obstruction, sleep disordered breathing, upper airwayresistance syndrome and snoring by manipulating the structures of theoropharynx, including the tongue and the palate.

2. Description of the Related Art

Respiratory disorders during sleep are recognized as a common disorderwith significant clinical consequences. During the various stages ofsleep, the human body exhibits different patterns of brain and muscleactivity. In particular, the REM sleep stage is associated with reducedor irregular ventilatory responses to chemical and mechanical stimuliand a significant degree of muscle inhibition. This muscle inhibitionmay lead to relaxation of certain muscle groups, including but notlimited to muscles that maintain the patency of the upper airways, andcreate a risk of airway obstruction during sleep. Because musclerelaxation narrows the lumen of the airway, greater inspiratory effortmay be required to overcome airway resistance. This increasedinspiratory effort paradoxically increases the degree of airwayresistance and obstruction through a Bernoulli effect on the flaccidpharyngeal walls during REM sleep.

Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2to 4% of the population in the United States. OSA is characterized by anintermittent cessation of airflow in the presence of continuedinspiratory effort. When these obstructive episodes occur, an affectedperson will transiently arouse, regain muscle tone and reopen theairway. Because these arousal episodes typically occur 10 to 60 timesper night, sleep fragmentation occurs which produces excessive daytimesleepiness. Some patients with OSA experience over 100 transient arousalepisodes per hour.

In addition to sleep disruption, OSA may also lead to cardiovascular andpulmonary disease. Apnea episodes of 60 seconds or more have been shownto decrease the partial pressure of oxygen in the lung alveoli by asmuch as 35 to 50 mm Hg. Some studies suggest that increasedcatecholamine release in the body due to the low oxygen saturationcauses increases in systemic arterial blood pressure, which in turncauses left ventricular hypertrophy and eventually left heart failure.OSA is also associated with pulmonary hypertension, which can result inright heart failure.

Radiographic studies have shown that the site of obstruction in OSA isisolated generally to the supralaryngeal airway, but the particular siteof obstruction varies with each person and multiple sites may beinvolved. A small percentage of patients with OSA have obstructions inthe nasopharynx caused by deviated septums or enlarged turbinates. Theseobstructions may be treated with septoplasty or turbinate reductionprocedures, respectively. More commonly, the oropharynx and thehypopharynx are implicated as sites of obstruction in OSA. Some studieshave reported that the occlusion begins with the tongue falling back inan anterior-posterior direction (A-P) to contact with the soft palateand posterior pharyngeal wall, followed by further occlusion of thelower pharyngeal airway in the hypopharynx. This etiology is consistentwith the physical findings associated with OSA, including a large baseof tongue, a large soft palate, shallow palatal arch and a narrowmandibular arch. Other studies, however, have suggested that increasedcompliance of the lateral walls of the pharynx contributes to airwaycollapse. In the hypopharynx, radiographic studies have reported thathypopharyngeal collapse is frequently caused by lateral narrowing of thepharyngeal airway, rather than narrowing in the A-P direction.

OSA is generally diagnosed by performing overnight polysomnography in asleep laboratory. Polysomnography typically includeselectroencephalography to measure the stages of sleep, anelectro-oculogram to measure rapid eye movements, monitoring ofrespiratory effort through intercostal electromyography or piezoelectricbelts, electrocardiograms to monitor for arrhythmias, measurement ofnasal and/or oral airflow and pulse oximetry to measure oxygensaturation of the blood.

Following the diagnosis of OSA, some patients are prescribed weight lossprograms as part of their treatment plan, because of the associationbetween obesity and OSA. Weight loss may reduce the frequency of apneain some patients, but weight loss and other behavioral changes aredifficult to achieve and maintain. Therefore, other modalities have alsobeen used in the treatment of OSA, including pharmaceuticals,non-invasive devices and surgery.

Among the pharmaceutical treatments, respiratory stimulants and drugsthat reduce REM sleep have been tried in OSA. Progesterone, theophyllineand acetozolamide have been used as respiratory stimulants, but eachdrug is associated with significant side effects and their efficacy inOSA is not well studied. Protriptyline, a tricyclic antidepressant thatreduces the amount of REM sleep, has been shown to decrease thefrequency of apnea episodes in severe OSA, but is associated withanti-cholinergic side effects such as impotence, dry mouth, urinaryretention and constipation.

Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating obstructive sleep apnea.

SUMMARY OF THE INVENTION

Methods and devices for manipulating soft tissue are provided. Atissue-engaging member is used to engage a region of soft tissue. Thetissue-engaging member is attached to another site that is less mobilethan the soft-tissue engaged by the tissue-engaging member. The lessmobile site may be a bone or connective tissue attached to bone.

Methods and devices are disclosed for manipulating the palatal tissue.An implant is positioned within at least a portion of the soft palateand may be secured to other surrounding, less mobile structures such asthe hard palate or the mucosa overlying the hard palate. The implant maybe manipulated to displace at least a portion of the soft palate in ananterior or lateral direction, or to alter the tissue tension orcompliance of the soft palate.

In one embodiment, a method for treating a patient is provided,comprising providing a palate remodeling system, the system comprising atether support and a palate element, the palate element comprising atissue anchor and a tether, inserting the tissue anchor into a softpalate of a patient, attaching the tether of the palate element to thetether support, folding a first surface of the soft palate toward afirst surface of the hard palate, and fixing the tether support withrespect to the hard palate. Fixing the tether support with respect tothe hard palate may comprise fixing the tether support to mucosal tissueoverlying the hard palate. Fixing the tether support may be performedbefore attaching the tether to the tether support. The tissue anchor maybe an expandable tissue anchor and the tissue anchor and the tether maybe pre-attached. The palate remodeling system comprises a second palateelement and optionally a second tether support. The tether support maybe an adjustable tether support. The method may also further comprisefolding a second surface of the soft palate toward a second surface ofthe hard palate, wherein the first surface of the hard palate is asuperior surface and the second surface of the hard palate is aninferior surface.

In another embodiment, a palate implant is provided, comprising ananchoring structure configured for attachment to a hard palate, and afirst spring element configured for insertion into a soft palate,wherein the first spring element comprises a proximal section attachedto the anchoring structure and a distal section having a paddleconfiguration. The anchoring structure may comprise a hard palatefastener and a fastener aperture. The first spring element may have anon-linear configuration, such as a curved configuration. The palateimplant may further comprise a second spring element configured forinsertion into the soft palate. The first and second spring elementshave a similar size and shape, such as a mirror-image configuration. Insome embodiments, first and second spring elements are configuredgenerally about 180 degrees apart with respect to the anchoringstructure. The first and second spring elements have an adjustableangular relationship with respect to the anchoring structure.

In another embodiment, a method for displacing a soft palate withrespect to a tongue of a patient is provided, comprising providing apalate implant, wherein the palate implant comprises a first springelement configured for insertion into the soft palate and having a firstend, a second end, a hinge therebetween, a delivery configuration and adeployed configuration, inserting the first spring element into the softpalate of a patient in the delivery configuration, and deploying thefirst spring element to the deployed configuration to displace a portionof the soft palate away from the tongue of the patient. The palateimplant may further comprise an anchoring structure attached to thefirst end of the first spring element, and may further compriseattaching the anchoring structure to a hard palate region of thepatient. In some embodiments, deploying the first spring element to thedeployed configuration comprises deforming the hinge of the first springelement by moving the anchoring structure toward the hard palate regionof the patient. Attaching the anchoring structure to the hard palateregion may be performed before or after deploying the first springelement to the deployed configuration. The palate implant may furthercomprise a second spring element configured for insertion into the softpalate and having a first end, a second end, a hinge therebetween, adelivery configuration and a deployed configuration, and the method mayfurther comprise inserting the second spring element into the softpalate of the patient in the delivery configuration and deploying thesecond spring element to the deployed configuration. In someembodiments, the second spring element is inserted into the soft palateat an orientation of about 180 degrees with respect to the first springelement.

In one embodiment of the invention, an implantable device formanipulating soft tissue is provided, comprising at least one tissueanchor; an elongate member attached to the at least one tissue anchor;and a securing assembly comprising a bony attachment structure and anelongate member securing structure, wherein the elongate member securingstructure is adapted to be movable relative to the bony attachmentstructure while the elongate member is secured to the elongate membersecuring structure. The bony attachment structure may be adapted forinsertion into the mandible. In some instances, the bony attachmentstructure has a cylindrical configuration and a threaded outer surface.The securing assembly may further comprise a moving interface componentadapted to move the elongate member securing structure. In someembodiments, the bony attachment structure comprises an internalsealable cavity and the elongate member securing structure comprises afluid seal adapted to provide a sliding seal within the internalsealable cavity of the bony attachment structure. The bony attachmentstructure may further comprise a pierceable membrane for accessing theinternal sealable cavity. The bony attachment structure may alsocomprise a threaded cylindrical internal cavity and the elongate membersecuring structure may comprise a cylinder having outer threadscomplementary to the threaded cylindrical internal cavity of the bonyattachment structure and a rotatably attached securing interface. Thebony attachment structure may also further comprise a longitudinalgroove and the rotatably attached securing interface comprises aprotrusion having a complementary configuration to the longitudinalgroove of the bony attachment structure. The bony attachment structuremay comprise an internal friction cavity and the elongate membersecuring structure may comprise a friction surface configured to providea frictional fit within the internal friction cavity of the bonyattachment structure. In some embodiments, the elongate member securingstructure is adapted to provide a sliding frictional fit within theinternal friction cavity of the bony attachment structure. In otherembodiments, the elongate member securing structure further comprises amanipulation interface adapted to reversibly engage a manipulation tool.In still other embodiments, the bony attachment structure comprises aninternal tapered cavity and the elongate member securing structurecomprises a base with at least two radially inwardly deflectable prongsadapted to engage the elongate member.

In one embodiment of the invention, a device for manipulating the tongueis provided, comprising a variable pitch spiral having a first portionwith a first pitch and a second portion with a second pitch, the spiralcomprising a biocompatible material dimensioned to fit within a tongue.The first portion may have a wide pitch and the second portion may havea narrow pitch. In other embodiments, the first portion has a narrowpitch and the second portion has a wide pitch.

In another embodiment, a method for manipulating soft tissue isprovided, comprising: accessing an adjustment structure attached to atleast one tissue anchor by a connector, the at least one tissue anchorengaging the soft tissue and the adjustment structure being fixedrelative to a body structure, the connector having a length between theat least one tissue anchor and the adjustment structure; and changingthe length of the connector between the at least one tissue anchor andthe adjustment structure by manipulating the adjustment structurewithout detaching the at least one tissue anchor from the adjustmentstructure. The tissue anchor may be at least partially located withinthe soft palate. The adjustment structure may be fixed relative to ahard palate.

In one embodiment, an implantable device for manipulating soft tissue isprovided, comprising: at least one tissue engaging structure; anelongate member attached to the at least one tissue anchor; and asecuring assembly comprising a bony attachment structure and a movablesecuring member, wherein the movable securing member may be adapted tobe movable relative to the bony attachment structure while the elongatemember may be secured to the movable securing member. The tissueengaging structure may be an anchor adapted to pierce the soft tissue.The movable securing member may be rotatable, slidable, and/orpivotable. The movable securing member may be a rotatable hub, or aspool. The bony attachment structure has a cylindrical configuration anda threaded outer surface. The securing assembly further may comprise amoving interface component adapted to move the movable securing member.The bony attachment structure may comprise an internal sealable cavityand the movable securing member may comprise a fluid seal adapted toprovide a sliding seal within the internal sealable cavity of the bonyattachment structure. The bony attachment structure may further comprisea pierceable membrane for accessing the internal sealable cavity. Thebony attachment structure may comprise a threaded cylindrical internalcavity and the movable securing member may comprise a cylinder havingouter threads complementary to the threaded cylindrical internal cavityof the bony attachment structure and a rotatably attached securinginterface. The bony attachment structure further may comprise alongitudinal groove and the rotatably attached securing interface maycomprise a protrusion having a complementary configuration to thelongitudinal groove of the bony attachment structure. The bonyattachment structure may comprise an internal friction cavity and themovable securing member may comprise a friction surface configured toprovide a frictional fit within the internal friction cavity of the bonyattachment structure. The movable securing member may be adapted toprovide a sliding frictional fit within the internal friction cavity ofthe bony attachment structure. The movable securing member further maycomprise a manipulation interface adapted to reversibly engage amanipulation tool. The bony attachment structure may comprise aninternal tapered cavity and the movable securing member may comprise abase with at least two radially inwardly deflectable prongs adapted toengage the elongate member.

In another embodiment, an implantable device for manipulating softtissue is provided, comprising: at least one tissue anchor; an elongatemember attached to the at least one tissue anchor; and a securingassembly comprising a bony attachment structure and a rotationalsecuring structure. The rotational securing structure may be a spool.

In another embodiment, a device for manipulating the tongue is provided,comprising a variable pitch spiral having a first portion with a firstpitch and a second portion with a second pitch, the spiral comprising abiocompatible material dimensioned to fit within a tongue. The firstportion may have a wide pitch and the second portion has a narrow pitch,or the first portion may have a narrow pitch and the second portion hasa wide pitch.

In another embodiment, an implantable device for manipulating softtissue is provided, comprising: at least one tissue anchor; a securingassembly comprising a bony attachment structure; an elongate memberattached to the at least one tissue anchor and having a length betweenthe at least one tissue anchor and the securing assembly; and a meansfor adjusting the length of the elongate member. The securing assemblymay further comprise the means for adjusting the length of the elongatemember.

In another embodiment, a tissue anchoring system for engaging tissue isprovided, comprising: at least one deformable hook element, the at leastone hook element comprising an elongate body having a proximal portionand a sharp distal end, wherein the at least one hook element whenunrestrained curls to form an arcuate structure; and a tether attachedabout the proximal portion of the at least one hook element. The atleast one deformable hook element may be a plurality of deformable hookelements. The plurality of deformable hook elements may be arrangedcircumferentially, or in a generally planar configuration. The hookelements when unrestrained may curl back toward themselves to form aloop-like structure. The tissue anchoring system may further comprise aband about the proximal portions of the hook elements. The tissueanchoring system may further comprise a proximal group of hook elementsand a distal group of hook elements. The hook elements may comprisesymmetrical U-shaped planar structures with sharp distal tips on eachend. The tissue anchoring system may further comprise a delivery devicehaving a lumen adapted to receive and restrain the hook elements in agenerally linear configuration, wherein the hook elements when advancedout of the delivery device curl back toward themselves to engage tissue.

In another embodiment, a tissue anchoring system for engaging softtissue is provided, comprising: at least one means for expandable curledtissue engagement; and a tether attached to the at least one means forexpandable curled tissue engagement.

In another embodiment, a tissue anchoring system for engaging softtissue is provided, comprising: a plurality of deformable hook elementsspaced circumferentially about each other, each of the hook elementcomprising an elongate body having a proximal portion and a sharp distalend, wherein the hook elements when unrestrained curls to form anarcuate structure; and a tether attached about the proximal portion ofthe hook elements. The plurality of deformable hook elements maycomprise at least two pairs of deformable hooks elements joined togetherabout the proximal portions of their elongate bodies. The at least twopairs of deformable hook elements may be joined proximally by a band.The at least two pairs of deformable hook elements may comprise fourpairs of deformable hook elements. The at least two pairs of deformablehook elements may be arranged circumferentially, or in a generallyplanar configuration. The generally planar configuration may be agenerally planar nested configuration or a generally planar stackedconfiguration.

In one embodiment, a method for treating a patient is provided,comprising: providing a palate remodeling system, the system comprisingat least one tether support and at least one palate element, the atleast one palate element having at least one expandable tissue anchorjoined to at least one tether; accessing a region about a hard palate;inserting the at least one expandable tissue anchor through a firstpathway along the region about the hard palate to a soft palate;attaching the at least one tether of the at least one palate element tothe at least one tether support; positioning the at least one tethersupport about the hard palate; and fixing the at least one tethersupport about the hard palate. Fixing the at least one tether supportabout the hard palate may comprise fixing the at least one tethersupport to the hard palate, or to mucosal tissue overlying the hardpalate.

In another embodiment, a method for treating a patient is provided,comprising: providing a soft palate element having an attachment end andan expandable tissue-anchoring end; inserting the expandabletissue-anchoring end into the soft palate; securing the attachment endof the palate element to a body structure. The body structure may be apalatine bone, a hard palate, or a nasal turbinate.

In another embodiment, a method for treating a patient is provided,comprising: accessing a tissue anchor implanted in a soft palate, thetissue anchor having a deployment configuration and a removalconfiguration; deforming the tissue anchor to the removal configuration;and withdrawing the tissue anchor from the soft palate.

In still another embodiment, a method for treating a patient isprovided, comprising: accessing an adjustment assembly of a patient withan implanted adjustable soft palate remodeling system comprising theadjustment assembly and one or more soft palate elements inserted intothe soft palate; wherein at least one soft palate element may comprisean anchor and a tether secured to the adjustment assembly at a securingpoint on the adjustment assembly; and adjusting one or more soft palateelements by manipulating the adjustment assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, in which:

FIG. 1 is a schematic sagittal view of the pharynx.

FIG. 2 is a schematic elevational view of one embodiment of a tongueelement.

FIGS. 3A and 3B illustrate anterior and side elevational views of oneembodiment of a mandible securing assembly.

FIGS. 4A through 4D are cross sectional views through the oropharynx andmandible depicting implantation of one embodiment of the invention.

FIGS. 5A through 5C are cross sectional views through the oropharynx andmandible depicting another embodiment of the invention wherein thetongue elements are engaged to the lateral portions of the mandible.

FIGS. 6A and 6B are cross sectional views through the oropharynx andmandible illustrating another embodiment of the invention comprising adual-anchor device.

FIGS. 7A through 7F are cross sectional views through the oropharynx andmandible depicting transmandibular implantation of one embodiment of theinvention. FIGS. 7G through 7J are schematic cross sectional viewsdepicting the removal of an embodiment of the invention. FIGS. 7I and 7Jare detailed views of the distal anchors and removal tool in FIGS. 7Gand 7H.

FIGS. 8A and 8B depict one embodiment of the invention comprising aglossoplasty device with a T-shaped tissue anchor.

FIGS. 9A and 9B depict one embodiment of the invention comprising aglossoplasty device with a spiral tissue anchor.

FIGS. 10A and 10B depict one embodiment of the invention comprising aglossoplasty device with a flat pronged tissue anchor.

FIG. 11 illustrates one embodiment of the invention comprising aglossoplasty device with a pointed prong tissue anchor.

FIG. 12 illustrates one embodiment of the invention comprising aglossoplasty device with a dual pointed prong tissue anchor.

FIG. 13 illustrates another embodiment of the invention comprising aglossoplasty device with an umbrella tissue anchor.

FIGS. 14A and 14B depict embodiments of the invention comprising adistal anchor having a foam plug and T-tag core. The foam plug fullyencapsulates the T-tag in FIG. 14A and partially encapsulates the T-tagin FIG. 14B.

FIGS. 15A through 15C depict another embodiment of the inventioncomprising a glossoplasty device with a radially expandable slottedtissue anchor.

FIG. 16 depicts one embodiment of the invention where the proximal endof the tissue anchor comprises barbs for engaging tissue.

FIGS. 17A and 17B depict another embodiment of the invention comprisinga glossoplasty device with a dual radially expandable slotted tissueanchor.

FIGS. 18A and 18B depict another embodiment the invention comprising aradially expandable tissue anchor before and after expansion.

FIG. 19 depicts still another embodiment the invention comprising aradially expandable tissue anchor.

FIG. 20 depicts still another embodiment the invention comprising aradially expandable tissue anchor with barbs.

FIGS. 21A and 21B depict another embodiment the invention comprising aradially expandable tissue anchor before and after expansion.

FIGS. 22A and 22B depict another embodiment the invention comprising aradially expandable tissue anchor before and after expansion.

FIGS. 23A and 23B depict one embodiment the invention comprising asplayed tissue anchor before and after expansion.

FIGS. 24A and 24B depict one embodiment the invention comprising a dualsplayed tissue anchor before and after expansion.

FIGS. 25A through 25C illustrate one embodiment of the inventioncomprising an in situ formed anchor or plug.

FIGS. 26A through 26D illustrate one embodiment of the inventioncomprising a fillable anchor or plug.

FIG. 27 represents one embodiment of the invention comprising anelastomeric tether.

FIG. 28 represents one embodiment of the invention comprising a woundwire.

FIG. 29 represents one embodiment of the invention comprising a springcoil.

FIG. 30 represents one embodiment of the invention comprising one-sidedpneumatic tension assembly.

FIG. 31 represents another embodiment of the invention comprisingtwo-sided pneumatic tension assembly.

FIG. 32 represents one embodiment of the invention comprising a beadedtether.

FIG. 33 represents one embodiment of the invention comprising a barbedtether.

FIG. 34 depicts one embodiment of a tether having a serial arrangementof anchors.

FIG. 35 illustrates one embodiment of a branched tether with anchors.

FIG. 36 depicts a tether having two proximal ends.

FIG. 37 is a cross sectional view of one embodiment of the inventioncomprising a tether loop with an enlarged section.

FIG. 38 is a cross sectional view of one embodiment of the inventioncomprising a tether loop with tissue anchors along the tether loop.

FIG. 39 illustrates one embodiment of the invention comprising amandible securing assembly with a lumen.

FIGS. 40A through 40C represents one embodiment of the inventioncomprising a mandible securing assembly with a clipping interface.

FIGS. 41A and 41B illustrate one embodiment of the invention comprisinga mandible securing assembly with a tether securing bolt.

FIGS. 42A through 42D illustrate one embodiment of the inventioncomprising an adjustable mandible securing assembly with a non-rotatingtether interface.

FIGS. 43A through 43E illustrate another embodiment of the inventioncomprising a keyed tether interface.

FIGS. 44A and 44B illustrate an embodiment of an adjustable mandiblesecuring assembly with a keyed interface usable with the keyed tetherinterface in FIGS. 41A through 41E.

FIGS. 45A and 45B are cross sectional views of the adjustable mandiblesecuring assembly of FIGS. 42A and 42B before and after an adjustment.

FIGS. 46A and 46B illustrate an embodiment of an adjustable mandiblesecuring assembly with a keyed interface.

FIGS. 47A through 47D illustrate an embodiment of an adjustable mandiblesecuring assembly with a pierceable membrane.

FIGS. 48A and 48B illustrate an embodiment of a mandible securingassembly with a resistance plug.

FIGS. 49A through 49D illustrate an embodiment of a mandible securingassembly usable with a beaded tether.

FIGS. 50A through 50F illustrate another embodiment of a mandiblesecuring assembly comprising an inner resistance surface and tetherinterface.

FIGS. 51A through 51E illustrate another embodiment of a mandiblesecuring assembly comprising an expandable tether interface.

FIGS. 52A through 52F represent one embodiment of the inventioncomprising a rigid tongue splint.

FIGS. 53A and 53B represent another embodiment of the inventioncomprising a semi-rigid tongue splint.

FIGS. 54A and 54B represent one embodiment of the invention comprising avariable pitch tissue compression screw.

FIGS. 55A and 55B represent another embodiment of the inventioncomprising a tissue compression coil.

FIG. 56 represents another embodiment of the invention comprising abarbed tissue compression coil.

FIG. 57 represents another embodiment of the invention comprising abarbed tissue compression coil positioned on an implantation needle.

FIG. 58 represents another embodiment of the invention comprising abarbed tissue compression coil positioned on a fitted grooveimplantation needle.

FIGS. 59A and 59B represent one embodiment of the invention forimplantation of a tissue compression coil.

FIGS. 60A and 60B are perspective views of another embodiment of adistal anchor in the delivery and deployed configurations, respectively.FIGS. 60C and 60D are rear and frontal views of the distal anchor inFIG. 60B. FIG. 60E depicts a subcomponent of the distal anchor in FIGS.60B to 60D. FIG. 60F illustrates a tether looped through the distalanchor and FIG. 60G illustrates the tether knotted to the distal anchorand the tether ends attached to a securing assembly.

FIGS. 61A and 61B are inferior and superior perspective views of anotherembodiment of the securing assembly, respectively. FIG. 61C is anexploded superior perspective view of the securing assembly in FIG. 61B.FIGS. 61D to 61F are inferior, superior and side elevational views ofthe securing assembly, respectively. FIG. 61G is a side elevationalisolation view of the spool assembly. FIGS. 61H and 61I are alongitudinal cross sectional views of the securing assembly in FIG. 61Fin the locked and rotation configurations, respectively. FIGS. 61J and61K illustrate an implanted distal anchor and securing assembly beforeand during adjustment of the securing assembly, respectively.

FIG. 62A is a superior isometric view of one embodiment of a deliverytool system with a partial cut-away of the delivery tube of the deliverytool. FIGS. 62B and 62C are left elevational views of the delivery toolwithout the delivery tool housing and delivery tube in the loaded anddeployed configurations, respectively. FIG. 62D is an exploded view ofthe actuator handle and safety lock of the delivery tool.

FIGS. 63A and 63B are perspective and exploded views, respectively, ofone embodiment of a palate anchor.

FIGS. 64A to 64D are axial cross sectional views of various embodimentsof a delivery tube of the delivery tool for the palate anchor in FIG.64A.

FIG. 65 is a perspective view of a push rod for the palate anchor inFIG. 64A.

FIG. 66 is a schematic sagittal cross sectional view of the implantationof a palate anchor through the oral cavity.

FIG. 67 is a schematic sagittal cross sectional view of the implantationof a palate anchor through the nasal cavity.

FIG. 68 is a schematic sagittal cross sectional view of the soft andhard palate with a palate anchor anchored to the hard palate.

FIG. 69 is a schematic sagittal cross sectional view of the soft andhard palate with a palate anchor anchored to the mucosal tissueoverlying the hard palate.

FIG. 70A is a perspective view of one embodiment of a recapture tool.FIG. 70B is an exploded view of the recapture tool in FIG. 70A. FIG. 70Cis a superior exploded view of the distal end of the recapture tool.FIG. 70D is an axial cross sectional view of the recapture tool in theopen position as identified in FIG. 70A. FIG. 70E is an axial crosssectional view of the recapture tool in the closed position

FIGS. 71A to 71I are schematic views of one embodiment for recapturingan implanted anchor. FIG. 71C is a detailed view of FIG. 71B. FIG. 71Eis a detailed view of FIG. 71D.

FIG. 72 illustrates another embodiment of a recapture tool with acircumferentially closed distal end.

FIGS. 73A and 83B are schematic representations of soft palatesuspension toward the hard palate.

FIG. 74 is a schematic representation of a resilient remodeling implantplaced in the soft palate.

FIGS. 75A to 75F depict one embodiment for inserting a resilient implantinto the soft palate.

FIG. 76A depicts an embodiment of a resilient implant configured forattachment to the hard palate.

FIG. 76B depicts an embodiment of a resilient palate implant bilaterallyattached to the lateral pharyngeal structures.

FIGS. 77A and 77B depict another embodiment of a resilient implantplaced in the soft palate.

FIGS. 78A to 78D illustrate some embodiments for everting or folding thesoft palate onto the hard palate.

FIGS. 79A to 79E depict various embodiments of anchoring elements.

FIG. 80 is a schematic diagram depicting suspension of the soft palateto the hard palate using anchoring elements.

FIG. 81 is a cross-sectional schematic view of the hard and soft palatewith an implanted mesh anchor structure.

FIGS. 82A to 82C illustrates various embodiments for reshaping theairway.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A. Anatomy of the Pharynx

FIG. 1 is a sagittal view of the structures that comprise the pharyngealairway and may be involved in obstructive sleep apnea. The pharynx isdivided, from superior to inferior, into the nasopharynx 1, theoropharynx 2 and the hypopharynx 3. The nasopharynx 1 is a less commonsource of obstruction in OSA. The nasopharynx is the portion of thepharynx above the soft palate 4. In the nasopharynx, a deviated nasalseptum 5 or enlarged nasal turbinates 6 may occasionally contribute toupper airway resistance or blockage. Only rarely, a nasal mass, such asa polyp, cyst or tumor may be a source of obstruction.

The oropharynx 2 comprises structures from the soft palate 4 to theupper border of the epiglottis 7 and includes the hard palate 8, tongue9, tonsils 10, palatoglossal arch 11, the posterior pharyngeal wall 12and the mandible 13. The mandible typically has a bone thickness ofabout 5 mm to about 10 mm anteriorly with similar thicknesses laterally.An obstruction in the oropharynx 2 may result when the tongue 9 isdisplaced posteriorly during sleep as a consequence of reduced muscleactivity during REM sleep. The displaced tongue 9 may push the softpalate 4 posteriorly and may seal off the nasopharynx 1 from theoropharynx 2. The tongue 9 may also contact the posterior pharyngealwall 12, which causes further airway obstruction.

The hypopharynx 3 comprises the region from the upper border of theepiglottis 7 to the inferior border of the cricoid cartilage 14. Thehypopharynx 3 further comprises the hyoid bone 15, a U-shaped, freefloating bone that does not articulate with any other bone. The hyoidbone 15 is attached to surrounding structures by various muscles andconnective tissues. The hyoid bone 15 lies inferior to the tongue 9 andsuperior to the thyroid cartilage 16. A thyrohyoid membrane 17 and athyrohyoid muscle 18 attaches to the inferior border of the hyoid 15 andthe superior border of the thyroid cartilage 16. The epiglottis 7 isinfero-posterior to the hyoid bone 15 and attaches to the hyoid bone bya median hyoepiglottic ligament 19. The hyoid bone attaches anteriorlyto the infero-posterior aspect of the mandible 13 by the geniohyoidmuscle 20.

B. Tongue Remodeling

Embodiments of the present invention provide methods and devices formanipulating the airway. It is hypothesized that the laxity inpharyngeal structures contributes to the pathophysiology of obstructivesleep apnea, snoring, upper airway resistance and sleep disorderedbreathing. This laxity may be intrinsic to the oropharyngeal structuresand/or may be affected by interrelationships between pharyngealstructures and other body structures. For example, in some studies, thecure rates in selected patients undergoing UPPP is as low as 5% to 10%.(Sher A E et al., “The efficacy of surgical modifications of the upperairway in adults with obstructive sleep apnea syndrome” Sleep, 1996February; 19(2):156-77, herein incorporated by reference). These lowcure rates may be affected by continued occlusion of the airway bystructures unaffected by the surgery, such as the tongue. By biasing atleast a portion of the posterior tongue or base of the tongue in atleast a generally anterior and/or lateral direction, functionalocclusion of the oropharynx may be prevented or reduced. Typically, thisbias may be created by altering a distance or tension between a locationin the tongue and an anchoring site, such as the mandible. In otherinstances, the bias may be created by altering the length or amount of astructure located in the tongue. In some instances, the bias provided tothe tongue may only affect the mechanical characteristics tongue duringtongue movement or in specific positions or situations. Thus, thedynamic response of the tongue tissue to mechanical forces or conditionsmay or may not occur with static changes, although static changestypically will affect the dynamic response of the tongue tissue. Theembodiments of the invention described herein, however, are not limitedto this hypothesis.

Although surgical and non-surgical techniques for biasing the tongueanteriorly are currently available, these techniques suffer from severallimitations. For example, the Repose® system (InfluENT® Medical, NewHampshire) utilizes a bone screw attached to the lingual cortex of themandible and a proline suture looped through the posterior tongue andbone screw, where the suture ends are tied together at some point alongthe suture loop to prevent posterior tongue displacement. In one studyof 43 patients, four patients developed infections of the floor of themouth and required antibiotics. One patient developed dehydration causedby painful swallowing, requiring intravenous fluids, and another patientdeveloped delayed GI bleeding requiring hospitalization. (Woodson B T,“A tongue suspension suture for obstructive sleep apnea and snorers”,Otolaryngol Head Neck Surg. 2001 March; 124(3):297-303). In anotherstudy of 19 patients undergoing combined UPPP and Repose® implantation,two patients developed submandibular infection requiring antibiotics,and one patient developed a hematoma in the floor of the mouth requiringdrainage. In addition, one patient extruded the suture four weeks afterimplantation and another patient developed a persistent lump/globussensation at the base of the tongue requiring removal of the Repose®system. (Miller F R et al., “Role of the tongue base suspension suturewith The Repose® System bone screw in the multilevel surgical managementof obstructive sleep apnea”, Otolaryngol Head Neck Surg. 2002 April;126(4):392-8).

By developing a tongue remodeling system that can be adjusted before,during and/or after the initial implantation procedure, a device andmethod for treating a patient with breathing problems may be bettertolerated and less prone to treatment failure. For example, by adjustingthe tension or bias of the implant, suture migration, suture extrusion,and/or dysphagia may be avoided or corrected. In another embodiment ofthe invention, the tongue remodeling system alters the structuralcharacteristics of the tongue with an anterior or lateral bias forcerather than a fixed length anchoring of the tongue to a body structure.This bias may reduce dysphagia or odynophagia associated with existingtongue suspension devices and procedures. In other embodiments, thetongue may be remodeled by altering the tissue compliance of at least aportion of the tongue. By inserting a prosthesis into the tongue tissue,tongue tissue compliance, is changed and may alter the tongue responseto forces acting during obstructive sleep apnea. The change incompliance may or may not be associated with a change in the position ofthe tongue. In some instances, embodiments of the tongue remodelingsystem can be implanted through an antero-inferior access site of themandible. Implantation of the system that avoids the transoral route mayimprove infection rates that occur with other tongue related devices andprocedures.

C. Tissue Anchor

In one embodiment, depicted in FIGS. 2, 3A and 3B, the inventioncomprises a tongue remodeling system having one or more tongue elements22 and at least one securing assembly 24. As depicted in FIG. 2, atleast one tongue element 22 comprises a distal tissue anchor 26 attachedto a proximal tether 28. The distal anchor 26 typically is a soft tissueanchor adapted for implantation within the tongue 9. The soft tissueanchor 26 may comprise any of a variety of structures capable ofengaging the surrounding tissue. These structures may have pointed,sharp or blunt tissue engagement structures 30. In some instances, thedistal anchor 26 has a first reduced diameter configuration for deliveryinto the tongue tissue and a second expanded diameter configuration forengaging the surrounding tissue. In other embodiments, the distal anchor26 has a fixed configuration.

The securing assembly 24 is configured to provide a stable positionabout the mandible 13 or other structure adjacent to the mandible 13 andcomprises one or more securing interfaces 32 to which one or moreproximal tethers 28 may be secured. In some embodiments, the securingassembly 24 may comprise a bone anchor or bone screw, a clip, or astaple for attaching the proximal tether 28 to the bone. In otherembodiments, as illustrated in FIGS. 3A and 3B, the securing interface32 may provide a friction fit or mechanical interfit with the proximaltether 28 that may be reversed or altered without disengaging orloosening the securing assembly 24 from the bone. The securing assemblyin turn is attached to the bone using bone screws or anchors 34. In someembodiments, the friction fit or mechanical interfit is adjustable inone direction. In other embodiments, the friction fit or mechanicalinterfit is capable of bidirectional adjustment. In some embodiments,the proximal tether 28 and the securing assembly 24 may be integratedtogether. Various embodiments of the securing assembly 24 are describedin further detail below. Preferably, the remodeling system comprises onesecuring assembly 24 and one to three tongue elements 22, but oneskilled in the art may select other combinations of securing assembliesand tongue elements, depending upon the patient's anatomy and thedesired result.

By implanting one or more tongue elements 22 within the tongue 9,creating tension in the proximal tethers 28, and attaching the proximaltethers 28 to a securing assembly 24 located peripherally to the distalanchors 26, a directional bias may be created in the tongue 9 to resistposterior displacement. There need not be continuous tension present inthe proximal tethers 28. In some embodiments, tension is generated inone or more proximal tethers 28 only when the tongue 9 has beendisplaced a particular distance and/or a range of directions. Theperipheral site of the securing assembly is typically located about ananterior portion of the mandible 13 and may involve the external,internal or inferior surface of the mandible 13 or a combination ofthese surfaces. In some embodiments, a lateral or anterolateral locationabout the mandible 13 may be used.

FIGS. 4A to 4D depict one embodiment of the invention where the tongueelements 22 are inserted into the tongue 9 through an insertion siteinferior to the mandible 13, preferably but not always about theanterior portion of the mandible 13. In other embodiments, theimplantation pathway may originate from a location anterior or lateralto the mandible 13, and in still other embodiments, may also passthrough the mandible 13. The tongue elements 22 may be implantedpercutaneously into the tongue 9 using a hypodermic needle 36 or otherpiercing delivery tool known in the art. In some instances, the distalanchors 26 of the tongue elements are positioned about the base of thetongue, which is the portion of the tongue posterior to thecircumvallate papillae (not shown), but other locations within thetongue 9, such as the anterior portion 39, may also be used. Forexample, the distal anchors 26 may also be positioned in the dorsalregion 38 of the tongue 9. This position may have a better effect onresisting posterior tongue displacement against the pharyngopalatinearch. Once positioned, the distal anchor 26 is released from thedelivery tool 36. As shown in FIG. 4C, additional anchors 26 may bedeployed, if desired. The delivery tool 36 is then withdrawn, leavingthe proximal tether 40 trailing from the distal anchor 26 and accessibleby the physician. A securing assembly 24 may be attached to the mandible13 using minimally invasive techniques and the proximal tethers 40 ofthe tongue elements 22 are adjusted to an initial tension and secured tothe securing structures 32 on the securing assembly 24. In someembodiments, the initial tension is zero but increases with changes intongue position. In some embodiments, the securing assembly 24 ispreferably secured to the inferior or inner surface of the mandible 13to reduce visibility of the securing assembly beneath the skin 42. Thesecuring assembly 24 may be adapted to penetrate and attach to themandible 13, as depicted in FIG. 4D, or attach to the mandible surfacewith the use of an adhesive or tissue welding. In some embodiments, thesecuring structures may also be adjusted through an adjustmentinterface, described below, to further alter the tension in the proximaltether.

FIGS. 5A through 5C are inferior schematic views of an embodiment of theinvention where the tongue elements 22 have been inserted into theposterior tongue bilaterally and attached to securing assemblies 42located on the inferior surface of the bilateral mandible 13. Continuousor intermittent tension created within the tongue elements 22 causesremodeling of the posterior tongue not only in an anterior direction butalso a lateral direction. This may be advantageous by increasing tissuetension in the posterior tongue with less limitation of tongue movementin the antero-posterior direction.

FIGS. 6A and 6B depict another embodiment of the invention comprising atongue element 44 having a distal tissue anchor 46 and a proximal tissueanchor 48 joined by a tether 50. This device can be inserted into thetongue tissue using a single cutaneous delivery device 52 and accesspoint without accessing or inserting into the mandible or other bone. Toimplant a dual-ended tongue element 44, the needle or delivery tool 52is inserted percutaneously into the tongue 9 to a desired distallocation and in a direction along the desired tension pathway. Thedistal anchor 46 is released from the delivery tool 52 into the tonguetissue. The delivery tool 52 is withdrawn, gradually exposing the tether50. By applying proximal force to the delivery tool 52, tension may beformed within the tether 50. In some embodiments, the release mechanismfor the proximal tissue anchor 48 further comprises a force measurementcomponent that may assist the physician in determining the appropriaterelease position for the proximal tissue anchor 48. The measurementcomponent may comprise a calibrated spring or a piezoelectric crystalwith an analog or digital readout. When the desired tension and/orlocation for the proximal tissue anchor 48 are reached, the proximaltissue anchor 48 may be released from the delivery tool by withdrawal ofan outer sheath on the delivery tool 52 to expose the proximal tissueanchor 48, or by release of an engagement structure, such as a suture ordeflection of one or more biased prongs, that are engaged to theproximal tissue anchor 48. The tether tension allows the distal andproximal tissue anchors 46, 48 to come closer together, therebycompressing the tongue tissue between the anchors 46, 48 and alteringthe tongue configuration. In other embodiments, the dual-ended tongueelement 44 is implanted within the tongue 9 and creates intermittentrather than continuous tissue compression, depending on tongue position.

FIGS. 7A through 7F depict another embodiment of the invention, wherethe implantation pathway passes through the mandible 13 to access thetongue 9. A pathway or conduit through the mandible 13 or other bone maybe created using a bone drill 54 or other device known in the art. Asillustrated in FIGS. 7A and 7B, in some instances, the inferior skin 56of the lower jaw is drawn toward the anterior chin prior to accessingthe anterior mandible 13. Displacing the skin anteriorly provides accessthrough skin that normally faces inferiorly, thereby hiding the skinaccess site 59 at the inferior surface of the mandible 13 once theprocedure is complete. Referring to FIGS. 7C and 7D, once a pathway iscreated through the mandible 13, the delivery tool 36 may be used toinsert one or more tongue elements 22 into the tongue 9. A sheath orretractors may be inserted through the skin and bone conduit to maintainaccess and/or exposure to the bone during the procedure. In oneembodiment, a delivery tool 36 with a tongue element 22 is insertedgenerally through the mandible 13 to a desired location in the tongue 9,deployed and released from the delivery tool 36. Deployment of thedistal anchor 26 may also include expansion of the distal anchor 26, ifneeded. In FIG. 7E, the delivery tool 36 is then withdrawn, leaving theproximal tether 40 trailing from the distal anchor 26 and accessible bythe surgeon. Additional anchors 26 may be deployed, if desired. In someembodiments, an intra-mandible securing assembly 60, shown in FIG. 7F,may be attached or partially attached to the bone before, during and/orafter the implantation of the tongue elements 22. In one embodiment, theproximal tethers 40 are attached to a securing assembly 60 and thetension of the proximal tether 40 is adjusted as needed and secured tothe securing assembly 60. In some embodiments, the securing assembly 60may be engaged to the mandible surface or conduit surface. In otherembodiments, the tension of the tongue element(s) 22 alone is sufficientto keep the securing assembly against the mandible 13. In someembodiment, a portion of the securing assembly may be inserted prior toimplantation of the tongue elements 22. In FIG. 7C, for example, aconduit portion 61 of the securing assembly 60 is inserted through themandible 13 prior to use of the delivery tool 36.

In addition to securing the proximal tethers 40 of the tongue elements22 to the anterior portion of the mandible 13, other securing sites arealso envisioned, including the lateral portions of the mandible 13, thehyoid bone 15, the occiput, the thyroid cartilage 16, the tracheal ringsand any other structure about the head or neck.

The embodiments of the invention described above may be combined withother treatments for OSA, sleep disordered breathing, upper airwayresistance syndrome and snoring. These other treatments may also includeexternal devices such as CPAP, medications such as modafinil, othersurgical procedures, as well as other treatments of the tongue,including various forms of tongue debulking using RF ablation such asCoblation® by ArthroCare® ENT.

1. Distal Anchor

The distal anchor may have any of a variety of shapes adapted forimplantation within the tongue 9 and to resist migration, typicallycomprising one or more tissue engaging structures 30. Expandable anchorsmay include expandable slotted tubes, fibrous or porous polymer plugs orstructures, coilable wires, expandable barb structures or any otherdeformable or expandable structure or combinations thereof. In otherembodiments, the distal anchor 26 has a fixed configuration but isadapted to facilitate its insertion in one direction through the tongue9 or other soft tissue and to resist migration or displacement in atleast the opposite direction. Distal anchors 26 with a fixedconfiguration may have barbs, angled pins, hooks or other angled orramped structures capable of engaging surrounding tissue. The distalanchors may also be self-expandable or may require the application offorce to expand in size or surface area. For instance, in someembodiments of the invention, the distal anchor may have one or moredeformable tissue engagement structures that self-expand upon release ofthe distal anchor from the delivery tool to engage the surroundingtissue. In other embodiments, the distal anchor may engage or expandinto the surrounding tongue tissue upon the application of tension tothe proximal tether of the tongue element.

In some embodiments, the distal anchor has a first configuration with areduced cross-sectional profile to facilitate implantation of the distalanchor within the tongue, and a second configuration with an expandedcross-sectional profile to engage the surrounding tissue and/or resistmigration of the anchor within or out of the tongue. In furtherembodiments of the invention, the distal anchor may have a thirdconfiguration to facilitate removal of the distal anchor from thetongue. The third configuration may result from deformation of thedistal anchor to facilitate disengagement from the surrounding tonguetissue and/or to reduce the cross-sectional profile. Deformation of thedistal anchor may occur at one or more pre-engineered failure points ordeformation points on the distal anchor. One skilled in the art candesign a failure point to deform with a force greater than the upperlimit of forces generally acting on the distal anchor in its intendeduse.

FIGS. 7G through 7J depict the removal of an anchor previously insertedin FIGS. 7A through 7F. In FIG. 7G, the proximal tether 40 is disengagedfrom the securing assembly 60 and a removal tool 62 is passed along theproximal tether 40 to the distal anchor 26. In FIG. 7H, the distalanchor 26 is deformed such that the distal anchor 26 has a reduced crosssectional profile and/or disengages the surrounding tongue tissue. Thedeformation may occur by stabilizing or pulling on the proximal tetherand distal anchor while pushing and/or stabilizing the removal toolagainst the distal anchor. FIG. 7I depicts a cross sectional expandedview of the distal anchor 26 and removal tool 62 from FIG. 7G as theremoval tool 62 abuts the distal anchor 26. FIG. 7J depicts the distalanchor and removal tool from FIG. 7I following deformation of the distalanchor. After deformation, the removal tool 62 may be withdrawn from thetongue separately from the distal anchor 26 or together with the distalanchor 26. In some embodiments, the removal tool 62 surrounds the distalanchor 26 to reduce the risk of breakage or snagging of the distalanchor 26 during withdrawal from the tongue. The removal tool mayinclude any of a variety of structures capable of exerting sufficientforce against the distal anchor 26 to cause deformation. In someinstances, the removal tool 62 may be a catheter or large gauge needle.Preferably, the removal tool 62 is further adapted to slide or interfacewith the proximal tether 40 of the distal anchor to guide the removaltool 62 to the distal anchor 26. The adaptation may include a groove,channel or a lumen that can be placed about the proximal tether 40.

In some embodiments of the invention, the distal anchor may resistmigration by having an enlarged surface area that creates a frictionalor mechanical interface with the surrounding tissue, but is not limitedto this sole mechanism to resist migration. Examples of such distalanchors include a T-shaped anchor 64 depicted in FIGS. 8A and 8B, acoil-shaped anchor 66 in FIGS. 9A and 9B, and the flat-ended pronganchor 68 illustrated in FIGS. 10A and 10B. Tissue anchors having anenlarged surface area may be advantageous by reducing or avoiding tissuelaceration that may be associated with piercing-type anchors. In otherembodiments of the invention, the distal anchor comprises one or morecoils that are drawn taut during the implantation procedure and resume acoiled configuration upon release of tension on the wire coil. Inembodiments of the distal anchor comprising multiple coils, the coilslengths may be distinct or intertwined with other coils of the same ordifferent anchor. The ends of each coil may be attached to the same ordifferent point on the tether or coils of the tether. However, apiercing anchor 70 with hooks or barbs 72, as shown in FIG. 11, may alsobe used. The piercing structures need not be arranged on the distalanchor about the same circumference. FIG. 12 illustrates anotherembodiment of the invention where the piercing structures 72 are locatedat two separate circumferences of the distal anchor 70, but in otherembodiments, the piercing structures may be staggered anywhere along thelength of the distal anchor.

In some embodiments of the invention, the distal anchor 74 may furthercomprise one or more polymeric sheets 76 between or engaged to thetissue engagement structures 78 of the distal anchor 74. In one exampledepicted in FIG. 13, the polymeric sheets 76 may be attached to thetissue engagement structures 78 generally about one end of the distalanchor 74, thereby forming an umbrella-like structure upon expansionthat provides an increased surface area for resisting the migration ofthe distal anchor 74. In other embodiments, the polymeric sheets mayspan from one end of the distal anchor to the other end, thereby forminga generally enclosed shape.

Referring to FIGS. 14A and 14B, in one embodiment of the invention, atleast a portion of the distal anchor 80 may comprise a plug structure82. The term plug is used to describe any of a variety ofspace-occupying structures, including lattice, reticular, fibrous orporous plugs, discs or other structures. The plug 82 may comprise apolymer, a metal, a ceramic or combination thereof. The polymer mayoptionally be a resorbable polymer. The plugs may be expandable ornon-expandable. Expandable plugs may be self-expandable through the useof a shape memory material, a compressible material such as a foam, oran absorptive material that may expand in the presence of liquid. Theplugs may or may not be filled or saturated with one or more therapeuticagents that may alter tissue ingrowth, scarring or other physiologicaleffect, either systemically or locally about the tongue 9. These agentsmay include but are not limited to an antibiotic, a sclerosing agent, ananti-proliferative agent, growth factors, hormones and other therapeuticagents known in the art. The plug structure 82 may also be combined withother distal anchor designs discussed herein. FIGS. 14A and 14Brepresent embodiments of a distal anchor 80 comprising an expandablefoam plug 82 with a T-tag core 84. The T-tag 84 may be fullyencapsulated by the foam 82 as shown in FIG. 14A, or some portions 86 ofthe T-tag 88 may protrude from the foam plug 82, as shown in FIG. 14B.

Other distal anchor designs that may be used are shown in FIGS. 15Athough 22B. FIGS. 15A and 15B depict one embodiment of the inventioncomprising a tubular distal anchor 90 having a proximal end 92, a distalend 94 and at least one deformable zone 96 between the proximal end 92and the distal end 94. The deformable zone 96 is configured to deformradially outward and may comprise any of a variety of deformablestructures, including but not limited to struts 98, prongs, lattice,reticular, coiled or spiral structures. The deformation may occur as aresult of elastic deformation of the distal anchor 90, shape memoryeffects, or particular mechanical effects of the distal anchorconfiguration in response to applied force. In some embodiments, whenthe distal end 94 and/or proximal end 92 of the distal anchor 90 arepushed or pulled closer together, the deformable zone 96 bends in aradially outward direction. In one embodiment, the tether 28 is locatedthrough a lumen in the proximal end 92 of the distal anchor 90 and thedeformable zone 96 and attaches to the distal end 94 of the distalanchor 90. Referring to FIG. 15B, by pulling on the tether 28, thetether 28 moves in a proximal direction and brings the distal end 94 ofthe distal anchor 90 closer to the proximal end 92, causing radialexpansion of the deformable zone 96. In one embodiment, shown in FIG.15C, the position of the proximal end 92 is maintained during theexpansion of the deformation zone 96, by abutting a portion of thedelivery tool 36 against the proximal end 92 of the distal anchor 90 toprovide leverage and to resist proximal displacement during theexpansion process. The delivery tool 36 may comprise a sheath 102 forretaining the proximal end 92 of the distal anchor 90 during expansionto prevent angular displacement of the anchor 90 as force is appliedthrough the tether 28. In other embodiments, sufficient resistance isprovided by the contact between the proximal end 92 of the distal anchor90 and the tongue tissue to limit displacement of the proximal end 92with tension of the tether 28 and thereby allow deformable zoneexpansion. Referring to FIG. 16, resistance between the proximal end 92of the anchor 90 and the tongue tissue may be enhanced by tissueengagement members 104 on the proximal end, such as small hooks, barbs,or any of a variety of ramped surfaces inclined radially outwardly froma distal to proximal direction.

One skilled in the art can configure the deformable zone to provide anyof a variety of desired expanded anchor shapes. In addition to aplurality of longitudinally oriented circumferentially spaced slots 106depicted in FIGS. 15A and 15B, the slots 106 may also be arrangedserially along the longitudinal axis of the distal anchor 108, asdepicted in FIGS. 17A and 17B, to create two or more deformable zones110, 112. Each deformable zone 110, 112 need not have the samedeformation characteristics. The first deformable zone, for example, maybe configured for a larger expanded diameter compared to the seconddeformable zone.

Referring to FIG. 18A, in another embodiment, the deformable zone 114comprises angled circumferential slots 116, which, when expanded asshown in FIG. 18B, result in a spirally oriented deformation zone 118.FIG. 19 illustrates a spirally oriented deformable zone 120 of an anchor124 configured to maintain the position of the one end of the anchor 124while rotating the other end of the anchor. In one embodiment, theproximal end 126 of the distal anchor 124 is held in position by adelivery tool or catheter while the distal end 128 of the distal anchor124 is pulled and rotated proximally. In some instances, the tether 28has sufficient stiffness such that rotation of a tether 28 joined to thedistal end 128 of the anchor 124 is sufficient to cause twisting of theanchor 124. In other instances, the tether 28 attached to the distalanchor 124 may lack sufficient stiffness to transmit sufficient torqueto the distal anchor 124. To facilitate torque transmission to thedistal anchor 124, a stiff inner core of the delivery tool may extendinto the distal anchor to form a mechanical interfit with the distal end128 of the anchor 124 and that is adopted to rotate and deploy theanchor 124 with rotation in one direction of the delivery tool anddisengage from the anchor 124 when rotated in the other direction. Afterexpansion, the inner core may be disengaged from the distal anchor 124and withdrawn.

One or more surfaces of an anchor may also be further configured withprotrusions, indentations or one or more porous layers to further engagethe surrounding tissue. FIG. 20 is a further embodiment of the inventioncomprising teeth or pointed members 130 protruding from the struts 98 ofthe distal anchor 90 that may further enhance the tissue engagementcharacteristics of the distal anchor 90. In another embodiment, one ormore surfaces of a strut 98 may be polished by methods known in the art.In still another embodiment, portions of the distal anchor 90 maycomprise a drug-eluting surface. Preferably, the drug-eluting anchor maybe used to release agents that alter the tissue and scar formation aboutthe anchor. In some embodiments, fibrous tissue growth is encouraged toreduce the friability of the tissue surrounding the anchor. In otherembodiments, anti-proliferative agents such as rapamycin orcorticosteroids may be used to limit tissue growth. Other therapeuticagents may also be used, including antimicrobials, clot inhibitors,sclerosants, growth factors, hormones and other therapeutic agents knownin the art. More than one therapeutic agent may be eluted from thedrug-eluting surface, if desired. As mentioned previously, the distalanchor may also be covered with a bioabsorbable coating. Thebioabsorbable coating may result in inflammation and/or fibrous tissueformation about the distal anchor. The fibrous tissue formation may alsoalter the tension or compliance characteristics of the tongue element orsurrounding tongue tissue, and may be beneficial in reducing the risk ofanchor extrusion or migration.

Although a distal anchor having a circular cross-sectional shape may beused in some embodiments of the invention, other cross-sectional shapesof distal anchors may also be used, including, triangular, rectangular,oval, polygonal or any other shape. The distal anchor need not have thesame cross-sectional shape or size along its length. FIG. 21A depictsone embodiment of the distal anchor 132 comprising a squarecross-sectional shape with slots 134 between each surface 136 of theanchor 132. When expanded, the anchor forms an X-shaped anchor as shownin FIG. 21B. The slots, however, may be positioned in a variety ofconfigurations on the anchor as desired to achieve a particular expandedshape. In other embodiments, slots may be located within a surface 136of the anchor 132, in addition to or in lieu of slots between thesurfaces 136.

The shape of the slot and/or strut of the deformable zone need not beconstant along the length of the slot or strut, or between the slotsand/or struts of the same anchor. The struts may also be configured tocontrol the shape of the deformation by varying the strut dimensionsalong the length of the strut. In some embodiments, indentations orcreases in the struts may be used to cause an angular deformation of thestrut with expansion. In other embodiments, the struts may deform in acurved or looped fashion. For example, variations in the cross-sectionalshape, thickness and width of the struts may be used to provide a distalanchor that deforms asymmetrically in as least one dimension. This maybe advantageous for resisting migration of the anchor in a particulardirection. In FIGS. 22A and 22B, for example, struts 138 of thedeformable zone 140 expands with a proximal bias because of proximalregions 142 of narrower widths, which may be beneficial in resistingmigration from the proximal tension exerted through the tether 28.

In some embodiments of the invention, the deformable zone may compriseat least one prong with one end that is not joined to either the distalend or proximal end of the tube segment. When the distal end andproximal end of the tube segment is brought closer together, the freeend of the prong is able to splay outward and engage the tongue tissue.The strut may or may not have an intrinsic outward bias. FIGS. 23A and23B depict one embodiment of the invention comprising prongs 144attached to the distal end 146 of the anchor 148. When proximal tensionis placed upon the tether 28, the prongs 144 contact and slide away fromthe proximal end 150 of the anchor 146, thereby splaying in a radiallyoutward direction to engage the tongue tissue. In other embodiments, theanchor 152 comprises an alternating or other arrangement ofmulti-directional prongs 154, 156. In FIGS. 24A and 24B, alternatingdistal end and proximal end prongs 154, 156 are provided to engage thesurrounding tissue from multiple directions. Although the prongsdepicted in FIGS. 23A through 24B are flat prongs 144, 154, 156, theprongs may have any of a variety of cross-sectional shapes, includingtriangles, circles, square or any of a variety of other shapes. The endof each prong may be also configured with additional structures tomodify the tissue engagement characteristics of the anchor. In someembodiments, the prong ends may be configured with spheres or othersmooth surfaces to reduce the risk of tissue laceration from chronictension exerted by the tether. In other embodiments, the prong ends areconfigured with barbs or hooks to further enhance tissue engagement. Oneskilled in the art can configure or select the prongs with the desiredfeatures for a given patient's anatomy and pathophysiology.

In another embodiment of the invention, the distal anchor 500 comprisesat least one deformable hook element, and preferably a plurality ofdeformable hook elements 502, 504. The plurality of hook elements 502,504 may be spaced circumferentially and/or longitudinally on the distalanchor 500 in any of a variety of configurations, at regular orirregular positions. The hook elements 502, 504 may be arrangedindividually about the distal anchor or placed in one or more groupsabout the distal anchor 500. A tether is typically attached to thedistal anchor 500 about its proximal end 521. In the specific embodimentillustrated in FIGS. 60A to 60D, the distal anchor 500 comprises aproximal group 506 of four hook elements 502 and a distal group 508 offour hooks 504. The hook elements 502, 504 within each group 506, 508are spaced about 90 degrees apart and the proximal group 506 is offsetfrom the distal group 508 by about forty-five degrees. In otherembodiments, one or more of the angles between the hook elements 502,504 and/or hook groups 506, 508 may be different. For example, the hookelements may be spaced such that the distal anchor has a left/rightsymmetry but a smaller vertical profile than horizontal profile whenfully deployed into tissue. In still other embodiments, the hookelements may or may not have a left/right symmetry, and/or may havesimilar or dissimilar sizes, shapes and/or lengths. The hook elements502, 504 may be provided with sharp or tapered distal ends 510, 512 asdepicted in FIGS. 60A to 60E, but in other embodiments, the ends mayhave blunt or have other configurations. Each end of the hook elementneed not have the same configuration. The distal anchor 500 illustratedin FIGS. 60A to 60D may also be combined with other features andstructures described herein, including but not limited to biocompatibleor biodegradable coatings.

The distal anchor 500 in FIGS. 60A to 60D comprise groups 506, 508 ofsymmetrical U-shaped planar structures 514 with one hook element on eachend, as depicted in FIG. 60E, and restrained by a band 516 and an innercore 518 about their proximal ends 520, 522, as depicted in FIGS. 60Cand 60D. One of skill in the art can produce any of a variety ofexpandable hook structures for deployment in the tongue without undueexperimentation and will understand that the embodiments of theinvention are not limited to the arrangements of U-shaped symmetricalhook element structures. For example, in other embodiments, the distalanchor may have a unibody construction, or may comprise a plurality ofnon-symmetrical and/or multi-planar components. In one specificembodiment, the plurality of piercing or grasping elongate members maybe provided using one or more X- or asterisk-like structure formed intoa multi-planar structure. Each group may be formed from the same or adifferent X or asterisk-like structure.

As shown in FIG. 60A, the distal anchor 500 may comprise a low-profiledelivery configuration to facilitate minimally invasive implantation ofthe distal anchor 500 and, as shown in FIG. 60B, an expanded deploymentconfiguration to engage the surrounding son tissue. In the low-profiledelivery configuration, each hook element 502, 504 generally has astraighter configuration to facilitate insertion of the distal anchor500 into the soft tissue using a delivery device. The delivery devicemay be configured to restrain the hook elements in the straighterlow-profile configuration until the distal anchor is deployed. Asillustrated in FIG. 62A; one embodiment of the delivery device 700 fordeploying a distal anchor comprises a tubular body 702 with a pushrod704, spring structure or other structure for displacing a distal anchorout of the distal opening 706 of the tubular body 702. In otherembodiments, the tubular structure may be retracted or withdrawnrelative to the pushrod. One embodiment of a delivery device isdiscussed in greater detail below.

As each hook element is exposed relative to the distal opening 706 ofthe tubular body 702, the distal tip of each hook element is no longerrestrained and can revert back to its deployment configuration to engagethe surrounding tissue. In the embodiment depicted in FIG. 60B, thedistal ends 510, 512 of the hook elements 502, 504 are configured tocurl back onto themselves to form a loop-like structure 524. In otherembodiments, the hook elements may curl to a greater or lesser extent,have a tighter or looser curl, and/or may have a more angularconfiguration when deployed. In some embodiments, due to the expansionbias of the hook elements 502, 504 in the deployment configuration, asthe distal ends 510, 512 of the hook elements 502, 504 are partiallyexposed from the delivery tool, the expansion of the hook elements 502,504 may cause the proximal portions 520, 522 of the distal anchor 500 tobe quickly pulled out of the delivery tool unless restrained orcontrolled in some manner. In some instances, the rapid expansion of thehook elements 502, 504 out of the delivery tool may facilitate itsengagement of the surrounding tongue tissue by virtue of the rate withwhich the hook elements pierces or grabs the surrounding soft tissue.With a slower deployment speed, the soft tissue may get pushed away ordisplaced from the curling hook elements 502, 504, rather than beingengaged, captured, pierced or grasped. Additional features on the hookelements, including but not limited to tissue ingrowth surfaces orbarbs, may be used to enhance engagement of the tissue anchor to thesurrounding tissue in some instances when a slower delivery speed isdesirable but provides inadequate tissue engagement. Preferably, thedeformable or expandable piercing or grasping members of the distalanchor comprise a metal such as Nitinol or superelastic Nitinol, butother materials may also be used and are described in greater detailbelow.

Although the distal anchor structure shown in FIGS. 60A to 60D and inother figures are described in the context of tongue manipulation, suchstructures may be applicable to a variety of other tissue structures,anatomical locations and treatments. Other tissue structures may includebone, fat, ligament, tendon, liver, striated and smooth muscle. Otheranatomical locations may include the nasopharynx, soft palate, hardpalate, pharyngeal wall, GI tract, bronchial tree, biliary tree, andgenitourinary tract.

Referring to FIGS. 25A through 25C, in another embodiment of theinvention, the anchor or plug 157 may be at least partially formed insitu within the tongue 9. As shown in FIG. 25C, an injectable material159 may be formulated to set in situ, to form the anchor 157 or plug,possessing the desired shape, position and mechanical properties toengage or resist migration from the surrounding tongue 9 or other softtissue. A tether 28 may be positioned at the site of formation before,during or after the injection of the material 159. The portion of thetether embedded in the anchor or plug 157 may be configured to resistseparation from the material 159, typically by one or more transverseelements, but one skilled in the art will understand that any of avariety of protrusions or other three-dimensional structures may beused.

The anchor 157 may comprise an injectable material 159 having one ormore biocompatible liquid components, or one or more solid biocompatiblecomponents carried in one or more liquid biocompatible components. Asdepicted in FIG. 25B, the material 159 may be injected as a liquid orslurry into the tongue 9 or other soft tissue region by a syringe orother delivery tool 161. Upon mixing, the components cross-link,polymerize, or otherwise chemically react to create the in situbiocompatible, non liquid, static mechanical anchor 157 or plug, asshown in FIG. 25C. In one embodiment, the delivery tool 161 has at leasttwo injection lumens for delivering the components separately to thetarget site to prevent premature reaction of the components within thedelivery tool 161 or elsewhere.

Referring to FIG. 25A, in some embodiments, prior to injection of thematerial 159, the targeted tissue region may be dilated by use of atrocar, balloon catheter or other expandable structure, to open a tissuespace 163 in the tongue 9 to receive the injectable material 159. Duringdilation, the tissue space 163 may be deliberately sized and shaped, sothat the resulting material 159 injected into the tissue space 163 willpossess the size, shape, and physical characteristics to resistmigration within the surrounding soft tissue.

The biocompatible liquid component may comprise, e.g., an Elastin™media. Alternatively, the liquid component may comprise an oil or lowviscosity liquid that is biocompatible to impart the desired featuresand/or shape to the anchor 157. The solid component may be a polyvinylacetate (PVA) or foam that is appropriately sealed to providebiocompatibility. Other materials such as silicone rubber, elastomericpolymers and polytetrafluoroethylene (Teflon® Material, from DuPont) mayalso be selected. Alternatively, a powder, small spheres, microtubulesor shavings of solid material can be mixed with a slurry or liquid.

Referring to FIGS. 26A and 26B, alternatively, the injectable material159 may be injected into a fillable structure 165 that is itselfimplanted in a targeted tissue region. The fillable structure ispreferably pre-shaped, expandable to assume the desired inflated shape,position, and mechanical properties. A tether 28 may or may not beintegrated with the fillable structure 165.

As illustrated in FIGS. 26C and 26D, once suitably implanted, thefillable structure 165 is inflated by infusion of the injectablematerial 159, which is dispensed from a syringe or other delivery tool161. In one embodiment, the injectable material 159 may be formulated toset in situ within the finable structure 165, the fillable structure 165and its contents serving as an anchor 157 or plug, possessing the shape,position and mechanical properties to resist migration. It should beappreciated that, when an expandable fillable structure 165 is used tohouse the injectable material 159, a fluid (e.g. saline) or slurry thatdoes not set or cure in situ may be also used to form an anchor 157 orplug. Furthermore, the injectable material 159 may be formulated to beinjected as a gel that need not set or cure to perform its desiredfunction.

The finable structure 165 may comprise a bioresorbable material, such aspolyglycolic acid, a polymer used for resorbable sutures and otherdevices within the body. In this arrangement, once expandable fillablestructure 165 is resorbed, only the core of injectable material 159 willremain to serve as the anchor or plug. The fillable structure 165 mayalso have one or more porous regions. Each porous region may be fullthickness or partial thickness porous regions. One or more fullthickness porous regions may allow escape of trapped air, if any, duringthe injection procedure. Depending on the pore size, the full thicknessporous regions may also allow partial extrusion of one or morecomponents of the injectable material 159 from the fillable structure165 to interface with the surrounding tissue.

One or more partial thickness porous regions on the outer surface of thefillable structure 165 may allow tissue ingrowth into the fillablestructure 165 or increase the frictional resistance between the finablestructure 165 and the surrounding tissue to further resist migration.One or more porous regions may also be provided on the inner surface ofthe fillable structure 165 to allow the injectable material 159 to forman interlocking configuration with fillable structure 165 which canresist separation or movement at the interface between the fillablestructure 165 and the core formed in situ by the injectable material.

In one embodiment of the invention, the anchor is integral with a tetherand comprises a tubular elastic member wherein one or more regions ofthe elastic member are configured to expand and occupy a larger spacewhen the tubular elastic member is filled or pressurized with theinjectable material. In one embodiment the anchor portion of the tubularelastic member comprises a thin walled region configured to expand to agreater size than other portion of the tubular elastic member.

2. Tether

In some embodiments of the invention, the tethers of the tongue elementscomprise sutures or wires that are well known in the art. Such materialsare generally inelastic and may be useful to fix the distance betweenthe distal anchor and the proximal anchor or securing assembly. Forreasons previously mentioned, however, a tether with elastic propertiesor comprising structures that provide a length/tension relationship maybe preferred in some instances. A tether capable of lengthening inresponse to increased load or tension may be optimized to providesufficient bias to reduce the effects of oropharyngeal occlusion whileproviding a more physiologic range of tongue motion than that producedby fixed length tethers. Fixed length glossoplasty or suspension of thetongue may be the cause of odynophagia, dysphagia and deglutitionproblems seen with existing tongue remodeling devices, but the currentinvention is not limited to this purpose. A tether with elastomericproperties may be provided by using materials such as but not limited tourethane or silicone. One skilled in the art can select the particularmaterial, tether length, diameter, cross-sectional shape and otherfeatures based upon the desired effect, tolerances, and the particularpatient's anatomical characteristics. Other materials that may comprisethe tether include but are not limited to Nitinol, spring steel,tantalum, polyethylene, polyester, silk, polypropylene, polyolefin or acombination thereof.

Other tether configurations that may be used include passive and activevariable length or bias structures such as braided or woven structures,electropolymers, springs, coils, magnets or solenoids. Thus, in some ofthe embodiments, the tether configuration may actively change in lengthin length or configuration resulting from the application of externalenergy or force such as electrical current or magnets. These activetether configurations may be further configured with local or distalsensor components that may modulate the activity of the external energyor force acting on the active tether. The modulation may be influencedor triggered by detection of diaphragm movement or depolarizationactivity, nerve depolarization, pressure changes and/mechanical contactin the airway.

The tether may also be covered by a lubricious biocompatible coating. Inanother embodiment, the tether comprises a bioabsorbable coating thatmay cause scar or connective tissue formation about the tether. Scartissue formation may further enhance the effect of the glossoplastyimplant by tightening the tongue tissue and/or to resist migration ofthe implant.

In some embodiments, the proximal tether of the tongue element may beconfigured with one or more structures or surfaces capable of engagingat least a portion of the tongue tissue surrounding the tether so that adistal anchor is not required, or to distribute the tissue engagement.In still other embodiments, the tongue element may comprise multipledistal anchors and multiple tethers arranged in a serial or branchingfashion.

FIG. 27 depicts one embodiment of the invention comprising anelastomeric cord that may be used for the tether 28. The elastomericcord 154 may comprise single or multiple tightly wound elastomericmembers 56, as shown in FIG. 28. Referring to FIG. 29, in otherembodiments, the tether may comprise a structure having spring-like orresilient properties, such as a braided structure, a woven structure, ora metallic or polymeric coil 158.

The tether may also comprise a variety of other tension structures thatprovide length/tension relationships. FIG. 30 depicts one embodiment ofthe invention comprising a pneumatic casing 160 with a first tether 162fixed to one end of the pneumatic casing 160 and a second tether 164attached to a movable piston 166 within the casing 160 which is capableof reversible movement within the pneumatic casing 160 depending upontension exerted through the first and second tethers 162, 164. A vacuumchamber 168 provides a shortening bias to the second tether 164. Inanother embodiment of the invention, shown in FIG. 31, the pneumaticcasing 170 comprising a first movable piston 166 attached to a firsttether 164 and a second movable piston 172 attached to the second tether174. By having two movable pistons 166, 172 incorporated into thepneumatic casing 190, the casing 170 can remain in a fixed positionwithin the tongue 9 while distributing changes in distance between boththe first and second tether 164, 174, which may reduce the irritationand inflammation caused by excessive movement of any one part of thetether system.

The tether may be further configured to provide one or more structuresfor adjustable mechanical interfacing with the securing structure of theimplant. These structures may include bead structures 176, as shown inFIG. 32, or ramped structures 178 as shown in FIG. 33. The particularstructure on the tether 28 can be selected by one skilled in the artbased upon particular interface characteristics desired with thesecuring assembly.

Although in some embodiments of the invention, the tongue elementcomprises a single elongate tether having one proximal end, one distalend, and a single distal anchor attached to the distal end of thetether, other configurations of the tongue element are also envisioned.In one embodiment, depicted in FIG. 34, the tongue element 179 comprisesa tether 181, a distal anchor 183, and at least one additional anchor185, 187 along the length of the tether 181, arranged serially. Themultiple anchors 183, 185, 187 need not be of the same configuration andneed not be spaced regularly along the segment or length of tether 181.In another embodiment, depicted in FIG. 35, the tether 189 may have oneor more branches, 191, 193, 195. The branches 191, 193, 195 mayoriginate from the main tether trunk 197, or may branch from otherbranches 191, 193, 195 of the tether 189. In one embodiment, thebranching tether 189 had a single proximal end 199 and two or moredistal ends 201, 203, 205. Tissue anchors 207, 209 may be located alonga branching tether 189 at the distal ends 201, 203, 205, a branch point211, or any other position along the branching tether 189. The branches201, 203, 205 of the tether 189 need not be symmetrical in branchlength, diameter, elasticity, branch configuration or othercharacteristics.

In another embodiment, shown in FIG. 36, the tether 213 may comprise twoor more proximal ends 215, 217, that are attachable to the same ordifferent anatomical structures. A tongue element 219 having two or moreproximal attachments 221, 223 may be beneficial in limiting tonguemovement or distal anchor 225 movement in more than one direction. Thevarious features of the tongue element described above may be used invarious combinations to achieve the desired effect from the glossoplastysystem.

FIG. 37 depicts another embodiment comprising a tether loop 227 havingtwo ends 229, 231 wherein the two ends 229, 231 are joined and thetether loop 227 is engaged to a securing assembly 24. The tether loop227 may comprise one or more regions 233 of an expanded diameter or sizeto reduce the risk of the loop 227 cutting through the tongue 9 due tochronic tether tension and with tongue movement. The tether loop 227 mayhave a fixed region of increased diameter, a self-expanding region, aballoon or fluid expanding region or an in situ formed expanded region.

FIG. 38 illustrates another embodiment of the invention comprising atether 235 with two ends 237, 239 and at least one tissue anchor 241attached to the tether 235 between the two ends 237, 239. The two ends237, 239 of the tether 235 may be attached to the same site or samesecuring assembly, or at two different sites 243, 245. Although therelative locations of the two sites 243, 245 as shown in FIG. 38 aresymmetrical with respect to the midline of the tongue 9 and mandible 13,in other embodiments the location may be asymmetrical.

FIG. 60F depicts another embodiment of the invention, comprising atether 28 that is looped or threaded through the proximal end 521 of thedistal anchor 500 from FIG. 60B. Typically, the proximal end of thedistal anchor 500 is positioned about halfway between the first end 23and second end 25 of the tether 28, but may also be positioned at otherlocations between the first and second ends 23, 25. Referring to FIG.60G, one or more knots 27 are optionally provided to resist slippage ofthe distal anchor 500 along the length of the tether 28. One or moreknots 27 and/or other securing methods (e.g. gluing or melting theelongate member to itself) may also be used to prevent the distal anchor500 from separating from the tether 28 should a section of the tether 2between the knot(s) 27 and one of the ends 23, 25 be severed. Theoptional knot(s) 27 will keep the distal anchor 500 secured to thetether 28 and allow the remaining intact section of the tether 28 tomaintain its connection to the securing assembly 600. The connection ofthe tether 28 to the distal anchor 500 is typically performed at thepoint of manufacture, but in other embodiments of the invention, one ormore attachments may be performed at the point of use to allowcustomization of the tongue element. As mentioned previously, the distalanchor 500 is preferably implanted into the tongue prior the attachmentof the first and second ends 23, 25 of the tether 28 to the securingassembly 500, but in other embodiments, the distal anchor 500 and tether28 are pre-attached to the securing assembly 600 when the distal anchor500 is implanted.

3. Securing Assembly

As mentioned previously, bone anchors or screws, clips, staples andother devices well known in the art may be used for directly attaching atongue element 22 to a mandible 13 or other rigid structure. Preferably,however, a tether securing assembly 24 is provided to facilitateattachment, removal and/or adjustment of the tether 28 to an attachmentstructure. More preferably, tether securing structures 24 that allowadjustment in a minimally invasive manner are used. In some embodiments,one tether securing structure is provided for each tongue element 22 ofthe glossoplasty system. In other embodiments, more than one tongueelement 22 may be secured to each retaining structure.

FIG. 39 depicts one embodiment of an attachment structure 180. Theattachment structure 180 comprises one or more bone engaging elements toattach the attachment structure to a bone or other structure such as abone screw or anchor 34. Angled protrusions or tabs 182 projecting fromthe attachment structure 180 provide securing interfaces 32 may be usedto lodge and retain one or more tethers 28 through frictionalresistance. The tether 28 may be wound between the two angledprotrusions 182 to further enhance the frictional resistance between theprotrusions 182 and tether 28, and also to localize excess tethermaterial for access at a later date. If the tongue element 22 wassecured with excessive tension, the excess tether material may beunwound, loosened to a desired tension and rewound onto the protrusions182. Once the desired tension is determined over the course of days,weeks or months post-implantations, any excess tether material notrequired to secure the tether 28 to the attachment structure 180 may beremoved to reduce the infection risk from unnecessary foreign bodymaterial. In some embodiments of the invention, a conduit or bore holeis provided in the mandible 13 or other bone, an access hole 184 may beprovided in the attachment structures 180 and the attachment structure180 may be positioned directly over the conduit or bore hole.

FIGS. 40A through 40C depict another embodiment of attachment structurecomprising a bone screw 186 with a clamping interface 188 for retainingtethers 28. The clamping interface 188 comprises two opposing surfaces190, 192 or structures that are adapted to provide a frictional ormechanical interface with tethers 28 or other elongate members insertedwithin the clamping interface 188. The clamping interface 188 has anopen configuration depicted in FIGS. 40B and 40C to allow positioning ofone or more tethers 28 within the interface 188 and a closedconfiguration shown in FIG. 40A for retaining the tethers 28. The closedconfiguration may be achieved by crimping the two opposing surfaces 190,192 or by further structures of the clamping interface, such ascomplementary clasps or clip structures that are well known in the artto fix the opposing surfaces 190, 192 together. Referring to FIG. 40C,the clamping interface 188 may further comprise complementaryindentations 194 and protrusions 196 to further enhance the frictionalresistance of the interface in the closed configuration. The opposingsurfaces or structures of the clamping interface may also be configuredwith frictional surfaces that are well known in the art through the useof various materials, surface treatments or configurations. Frictionalsurface configurations may also include cross hatched surfaces orirregular porous surfaces.

FIGS. 41A and 41B illustrate another embodiment of the attachmentstructure 198 comprising a retaining lumen 200 for inserting one or moretethers 28 and accepting a retaining bolt 202 for securing the tethers200 within the retaining lumen 200. Typically the retaining bolt 202will comprise a threaded surface 204 that is complementary to a threadedsurface 206 of the retaining lumen 200.

In some embodiments of the invention, the securing assembly is capableof adjusting the tension acting on the tether without directly accessingand manipulating the tether. This may reduce the need to perform an openprocedure to access the securing assembly and locate small, hard-to-findtether ends. Preferably, the tension adjustment may be facilitatedthrough an adjustment tool interface that can be accessed in a minimallyinvasive manner.

As previously illustrated in FIGS. 7A through 7F, in some embodiments ofthe invention, the securing assembly 60 is adapted for insertion into aconduit created through the mandible 13 or other bone. A securingassembly 60 with a reduced or flush profile may be beneficial byminimizing or eliminating any palpability or visibility of the implant.Some patients may find that palpable or visible surface landmarks of theimplant are psychologically or cosmetically unacceptable. Although thesecuring assemblies described below are described in the context ofinsertion into a conduit through the mandible, these securing assembliesmay adapted for attachment to the exterior of the bone by providing anattachment structure with an aperture on the exterior surface of thesecuring structure capable of accepting a bone screw.

Referring to FIGS. 42A through 42D, in one embodiment of the invention,a securing assembly 217 comprises an elongate body 208 with a lumen 210and an inner threaded surface 212, and a core 214 with external surfacethreads 216 complementary to the threaded lumen surface 212 of the lumen210 and capable of forming a rotational interface with the elongate body208. The core 214 may be directly attached or attachable to one or moretethers 216 of the glossoplasty system. After implantation of the distalanchor in the tongue, tether tension can be adjusted by rotating thecore 214 within the threaded lumen 210 which in turn adjusts thedistance between the distal anchor and the core 214 within the lumen 210of the elongate body 208. In one embodiment, where the tether 216 isdirectly attached to the core 214, rotation of the core 214 with arotation tool 240 will adjust the tether tension and result intranslation of the core rotation into torque acting on the tether 216and distal anchor, which may or may not result in unacceptable rotationof the tether 216 and distal anchor. This torque effect may causeincreased tension in the tether 216 from twisting causing furtherreduction in the distance between the core and the distal anchor. Thetorque effect may cause rotational laceration of the tongue tissue aboutthe distal anchor. In other embodiments, however, the torque effect maybe advantageous in taking up excess slack in the tether.

The securing assembly 217 may be threaded on its external surface 222 toallow secure positioning of the elongate body 208 within the boneconduit of a bone. Although the lumen 210 is generally circular in crosssection, the cross sectional shape of the external surfaces 222 of theelongate body 208 need not be circular, and could be oval, rectangular,square, polygonal or any other of a variety of cross sectional shapes.The external surface 222 may also have other surface characteristics orstructures to resist migration, including but not limited to ridges,barbs, hooks, and/or porous surfaces for bone ingrowth. The elongatebody 208 may also comprise a flange on the proximal end 218 to resistmigration of the elongate body 208 in the distal direction. The proximalend 218 of the elongate body 208 is typically open ended to allowinsertion of the threaded core 214 after implantation of the elongatebody 208. In other embodiments, the proximal end 218 of the elongatebody 208 is partially closed and is configured to accept the threadedcore 214 at the distal end 220. In still other embodiments, the elongatebody 208 is open at both ends. Preferably, the distal end 220 of theelongate body 208 is partially closed to prevent accidental release andloss of the threaded core if the core is overadjusted while still opensufficiently to allow passage of one or more tethers into the elongatebody. In some embodiments of the invention, a slip interface is providedat the attachment of the tether to the distal anchor to resist rotationof the distal anchor with adjustment of tether tension.

As shown in FIG. 42A, the threaded core 214 is a cylindrical componentwith a proximal end 224, distal end 220, and a threaded external surface228 complementary to the threaded inner lumenal surface 212 of theelongate body 208. The threaded core 214 further comprises a firstpartial slot 230 that is generally perpendicular to the longitudinalaxis of the core 214 and a second slot 232 that is generally between thefirst slot, the external surface and the distal end of the core. Thesecond slot 232 is dimensioned to allow passage of at least the diameterof one tether 216 but to resist passage of the tether 216 when theexternal surface of the core 214 is in contact with the inner lumenalsurface 212 of the elongate body 208 and where the proximal end 234 ofthe tether 216 is configured to with an increased diameter, in someexamples, by tying the tether end 234 into one or more knots, or toattach the tethers end 234 to an enlarged surface area slippagecomponent, such as a rod, disc 236 or plate. The first and second slots230, 232 are generally dimensioned to align the center of the disc 236with the center of the distal end 226 of the core 214, but it is notrequired. Alignment of the centers allows the tether 216 to maintain agenerally stable position while the core 214 is rotated. If either thefirst or second slot 230, 232 does not include the center of the core214, the tether may wobble eccentrically when the core 214 is rotated.FIG. 42B illustrates one embodiment of the securing assembly where thetether 216 is attached to a disc 236, which is then passed through thesecond slot 232 and into the first slot 230. Although it is preferredthat the first slot 230 be generally perpendicular to the longitudinalaxis of the core 214 to evenly distribute frictional forces between thecore and tether end, this is not required. In some embodiments, thefirst slot 230 may be oriented within the range of about zero degrees toabout 180 degrees with respect to the longitudinal axis of the core 214.In other embodiments, the first slot 230 is oriented between about 45degrees and 135 degrees, and in still other embodiments to about 75degrees to about 110 degrees. The core 214 further comprises amechanical interface 238 on its proximal end 224 for engaging arotational tool 240. As shown in FIGS. 42C and 42D, when the core 214 isrotated within the lumen 210, the position of the core 214 with respectto the lumen 210 is changed, thereby adjusting the tension in the tether216. The first slot 230, second slot 232, and/or slippage component 236may be covered with PTFE or another lubricious coating to minimizerotation of the tether 216 from rotation of the core 214 due to frictionbetween the tether/slippage component 236 and core 214.

FIGS. 43A through 43E depict another embodiment of the invention forrestricting rotation of the tether. Here, the core 242 is rotatablyattached to an intermediate tether interface 244 by a rod 246 or otherstructure. The intermediate tether interface 244 may be any structurethat is rotatably attached to the core 242 and comprises one or morekeyed structures 248 that form a partial mechanical interfit with acomplementary groove or track 250 on the inner threaded surface 252 ofthe elongate body 254 that allows sliding of the intermediate tetherinterface 244 along the longitudinal axis of the elongate body 254 whilerestricting rotation of the intermediate tether interface 244. Thegroove 250 typically has a generally linear configuration orientedparallel to the longitudinal axis of the elongate body 254, but thegroove 250 may also have other configurations and orientations. In someembodiments, the groove may have a spiral configuration within the innerthreaded surface 252 of the elongate body, thereby allow some torquetransmission to the tether. The pitch of the spiral configuration may beconstant or variable. For example, in some embodiments, the groove mayhave a tighter pitch proximally, so that it the keyed structure canimpart greater rotation to the tether as the longitudinal displacementrange limit is reached. The keyed structure 248 may comprise any of avariety of shapes sufficient to restrict rotation and need not beexactly matched in cross sectional shape and/or surface area to thegroove or tract. The keyed structure 248 and/or the groove of theelongate body 250 may be coated with PTFE and/or other lubriciouscoating to reduce friction and promote sliding of the keyed structure248 long the groove 250. The keyed structure 248 depicted FIGS. 43B and43C are square shaped, while the keyed structures 256 depicted in FIGS.43D and 43E are triangular.

FIGS. 44A and 44B are cross sectional and end elevational views of oneembodiment of the securing assembly 257 configured with a keyed groove250 and inner threaded surface 252 to accept a threaded core 242attached to a keyed intermediate tether interface 244.

The intermediate tether interface 244 may be configured with a varietyof structures to which one or more tethers may be attached. FIG. 43Bdepicts a tether interface 244 configured with a single hole 258 toaccept a single tether, while FIG. 43C depicts another tether interface260 configured with three holes 256 capable of accepting up to threetethers. FIG. 431) depicts still another tether interface 262 with threeeyelet attaching sites 264, while FIG. 43E illustrates a tetherinterface 266 with circular post 268 capable of engaging a number ofattached tethers.

FIGS. 45A and 45B depict one embodiment of the invention utilizing thecore 242 and tether interface 244 depicted in FIG. 43A and the securingassembly 257 shown in FIGS. 44A and 44B. The keyed structure 248 of thetether interface 244 remains in the groove 250 or tract of the elongatebody 254 to restrict rotation of the interface 244. The rod 246 of thethreaded core 242 and/or the rod lumen 290 of the tether interface 244may be coated with PTFE and/or other lubricious coating to reducefriction at the rod rotation site.

In another embodiment of the invention, shown in FIGS. 46A and 46B, asecuring assembly 292 comprises an elongate body 294 with an unthreadedlumen 296 containing a drive screw 298 and a keyed tether interface 300.The drive screw 298 is supported within the unthreaded lumen 296 bythreadless supports 302, 304 that allow the drive screw 298 to remain inthe same general location when rotated. The keyed tether interface 300is manipulable using a drive screw 298. The keyed tether interface 300has a threaded opening 306 that is complementary to the threads 308 ofthe drive screw 298. Rotation of the drive screw 298 causes movement ofthe keyed tether interface 300 along the longitudinal axis of theunthreaded lumen 296 of the securing assembly 292. Although theembodiment shown in FIGS. 46A and 46B depict a drive screw 298 locatedoff-center from the longitudinal axis of the elongate body 294, thedrive screw 298 may be configured with respect to the elongate body 294and tether interface 300 at any of a variety of locations relative tothe central longitudinal axis. One skilled in the art can select thediameter of the drive screw 298 and the thread pitch of the drive screw298 and threaded lumen 306 of the tether interface 300 to achieve thedesired adjustment characteristics.

Referring to FIGS. 47A through 47D, in one embodiment of the invention,the securing assembly 310 comprises a sealed cavity 312 wherein onesection of the sealed cavity 312 comprises a sealed access interface 314and a second portion of the sealed cavity comprises a sliding seal 316attached to a tether 28. The sealed cavity 312 may be filled with avolume of gas or preferably a liquid 316 that can be changed by addingor removing the fluid through the access interface 314. The sliding seal316 is configured to move with changes in fluid volume of the sealedcavity 312. As shown in FIGS. 47B and 47C, the access interface 314 ispreferably configured as a self-sealing pierceable membrane 318 so thatthe sealed cavity may be accessed with a hypodermic needle 320 that ispercutaneously inserted through the membrane 318 in a minimally invasivefashion. Alternatively, the access interface 314 may comprise any of avariety of sealed mechanical valves or other interfaces that are wellknown in the art. The securing assembly 310 shown in FIGS. 47A through47C further comprise a flange 322 at the proximal end of the securingassembly to restrict further distal migration of the securing assembly.FIG. 47D depicts an alternative embodiment of the securing assembly 324lacking a flange and comprising a threaded or frictional surface 326 onat least a portion of the external surface 328. Limiting the threaded orfrictional surface 326 to only a portion of the external surface 328 mayfacilitate insertion of the securing assembly 310 into a bony conduitwhile still providing sufficient friction to resist migration of theassembly 310. Although the tether 330 depicted in FIGS. 47A through 47Dis embedded into the sliding seal 316 of the securing assembly 310, thesliding seal 316 may also be configured with any of a variety ofattachment structures to allow attachment of one or more tethers to thesliding seal 316.

In one embodiment of the invention, illustrated in FIGS. 48A and 48B, asecuring assembly, 332 comprises a tapered elongate body 334 throughwhich one or more tethers 336 may be passed into or through the lumen338 of the elongate body 334. The tethers 336 may be secured to thesecuring assembly 332 by a frictional core 340 that can be snuglyinserted into the tapered lumen 338 of the tapered elongate body 334.The frictional core 340 may comprise any of a variety of frictionalmaterials, including silicone, rubber, metal, polymers or a combinationthereof. While the frictional core 338 forms a friction fit with thetether 336, the fit to the tapered lumen 338 may be frictional ormechanical. The surface of the lumen 338 may or may not be coated withfrictional materials to further enhance the frictional securing of thetethers 336 between the core 340 and lumen 338. The frictional core 340may be inserted and removed through a recessed interface 342 that isconfigured to accept a complementary core attachment tool. Alternativelyor additionally, the frictional core 340 may also comprise a patterned,rough or porous surface, such as a knurled or grooved surface.Alternatively, the frictional core 340 may comprise a protrudingstructure with can be engaged with forceps or other grasping tool forinsertion and/or removal.

In one embodiment of the invention, shown in FIGS. 49A through 49D, asecuring assembly 344 comprises an elongate body 346, a tapered lumen348, and a pronged core 350 capable of forming a mechanical stop orfrictional surface to restrict movement of one or more tethers 352. Thetapered lumen 348 comprises a proximal threaded lumen 352 and a distaltapered lumen 354 through which a tether 356 may be passed. The prongedcore 350 comprises a proximal threaded external surface 358 that iscomplementary to the proximal threaded lumen 352 of the elongate body346, and one or more distal prongs 360 that are capable of inwarddeflection. When the pronged core 350 is inserted into the elongate body346, as depicted in FIG. 49C, as the pronged core 350 is rotated andadvanced distally, the prong or prongs 360 are deflected radially inwardby the tapered lumen 354. In some embodiments, shown in FIGS. 49Bthrough 49D, the distal ends 362 of at least some prongs may be curvedor angled inward to form a mechanical stop interface capable ofrestricting a beaded tether 356 or other similarly configured tetherswith segments of increased cross sectional area. In other embodiments,the distal ends 362 of the prongs 360 are capable of reducingsufficiently to form a frictional aperture that is capable of resistingsliding of a tether about the prong ends 362.

Referring to FIGS. 50A through 50F, another embodiment of the inventioncomprises an elongate body 364 with a frictional internal lumenalsurface 366 and a frictional core 368. The frictional core 368 isconfigured to resist movement within the internal lumenal surface 366 byexertion of force within the broad range of force expected byphysiologic activities acting on one or more attached tongue elements,but is also capable of movement with the application of supraphysiologicforces through a frictional core movement tool 370. One embodiment ofthe movement tool 370 is depicted in FIG. 50B. The interface 372 betweenthe movement tool 370 and the frictional core 368 may comprise any of avariety of mechanical interfaces known in the art sufficient to transmitadequate pulling and pushing force to the frictional core. The interface372 shown in FIGS. 50A and 50C though 50F allow engagement of thefrictional core 368 following insertion and rotation of the movementtool 370 with one or more arms 374 capable of resisting dislodgementfrom the frictional core 368 when in the rotated position.

In still another embodiment of the invention, illustrated in FIGS. 51Ato 51E, the securing assembly 376 comprises an elongate body 378 with alumen 380 and an expandable tether core 382. The expandable tether core382 is configured to allow attachment of one or more tethers 384 and toalso reversibly radially expand and contract such that the expandedradius of the core 382 is capable of forming a frictional and/ormechanical fit with the lumen wall 386 of the elongate body 378. In oneembodiment of the invention, depicted in FIGS. 51A through 51E, theexpandable core 382 comprises a proximal end 388 and a threaded distalend 390, a threaded drive screw 392 through the proximal end 388 andthreadably engaged to the threaded distal end 390, and one or moreexpandable members 394 between the proximal end 388 and distal end 390.When the drive screw 392 is rotated, as shown in FIG. 51C, the distalend 390 of the expandable core 382 is brought closer to the proximal end388, causing deformation of the expandable members 394 which can thenengage the lumen wall 386, as shown in FIG. 51E. The proximal end 388 ofthe expandable tether core 382 may have a flange 396 to facilitateengagement by a deployment tool 398. The deployment tool 398 havegrasper 400 adapted to engage and hold the flange 396 while anextendable shaft 402 can form an interfit with the drive screw 392 androtate the drive screw 392.

In another embodiment of the invention, the securing assembly comprisesa spool or rotation assembly for adjusting the tether length or tethertension between the securing assembly and distal anchor. Referring toFIGS. 61A to 61I, in one embodiment of the invention, the securingassembly 600 comprises a fastener interface 602 for attaching thesecuring assembly 600 to a bone or other tissue and a spool assembly604, the spool assembly 604 comprising a spool 606 and a spool lock 608.The spool lock 608 allows the rotation of the spool 606 to take up orrelease a portion of the tether when desired, while resistingunintentional uptake or release of the tether at other times. In thespecific embodiment depicted in FIGS. 61A to 61I, the spool 606comprises one or more spool hubs 610 onto which one or more tethers maybe wound or unwound. Optionally, one or more flange structures 612, 614are provided on the spool 606 to help maintain the tether on the spoolhub 610. In other embodiments, grooves or a slip-resistant surface onthe spool hub may be used to maintain the tether on the spool hub, withor without spool flanges. Typically, two flange structures 612, 614 areprovided, but in other embodiments of the invention, only one flangestructure is needed as other portions of the securing assembly housing616 may act to maintain the tether on the spool hub 610. The spool hub610 typically has a circular cross-section, but any of a variety ofother cross-sectional shapes may also be used. Furthermore, although thespool hub 610 described, for example, in FIG. 61G comprises acylindrical surface, the spool hub may be any structure capable ofwinding a tether about it, e.g. in some embodiments, the spool hub maybe the region where two flanges are joined.

The spool may further comprise one or more engagement structures forengaging the tether or elongate element. For example, in FIG. 61D, theinferior flange 612 of the spool 606 comprises one or more holes 618 forattaching the tether. One of skill in the art will understand that anyof a variety of alternative engagement structures may be provide on thespool, spool flange or spool hub, including hooks, clips, clasps, crimpstructures or any combination thereof.

In a further embodiment of the invention, the spool assembly maycomprise two or more spools for winding the tether. Use of multiplespools may allow the use of smaller spools and/or use of non-circulartether uptake paths, which may allow the construction of securingassemblies having a reduced profile compared to securing assembliescomprising a single large spool.

The spool assembly 604 may further comprise a spool adjustment interface620. Referring to FIGS. 61H and 61I, the spool adjustment interface 620is typically located at the center of the spool 606 and is configured toform an interfit with an adjustment tool 621 for rotating the spool 606.The adjustment tool 621 may optionally have a sharp distal end so thatthe adjustment tool may also be used to provide direct access to thespool 606 without the preforming the access pathway, or having to use acannula, introducer, trocar or access needle first. In furtherembodiments, the adjustment tool 621 may also be used to displace thespool 606 in one or more directions. Spool displacement, whetherperpendicular to its rotation axis or longitudinally along its rotationaxis, as depicted in FIGS. 61H and 61I, may be used to switch the spoolbetween its locking and rotation configurations. In other embodiments,spool displacement may be used to wind the tether onto a secondary spoolhub of the spool having a different diameter to provide a different rateof tether winding per rotation, for example, on a frusta-conical spoolhub.

To facilitate the insertion of the adjustment tool 621 into the spooladjustment interface 620, the adjacent flange 612 may have a tapered orconical surface 623 to help guide an adjustment tool 621 into the spooladjustment interface 620. Other tapered or grooved structures 623 on thesecuring assembly 600 may also be provided to guide the adjustment tool621 from other locations about the securing assembly 600.

In other embodiments, the spool adjustment interface may be provided ona cog or disc, which in turn is configured to rotate the spool foradjusting the tether. Likewise, the cog may also be reversiblydisplaceable along its rotation axis and/or off its rotation axis tolock rotation of the spool.

The interface between the spool and the spool housing may be configuredin a number of ways. As depicted in FIG. 61C, spool rotation is providedby a generally cylindrical or circular rotation surface 622 that rotatesin or about a hole 624, lumen or other arcuate surface of the spoolhousing 616 to provide rotation. The circular rotation surface. 622 maybe located on the spool hub 610, spool flanges 612, 614 or other sectionof the spool 606. In other embodiments, the spool may comprise a tubularlumen which rotates about a pin or an axle structure of the spoolhousing. The tubular lumen may be concentric or eccentric with the spoolhub.

In some embodiments of the invention, the interface between the spooland the spool housing provides sufficient mechanical or frictional forceto generally resist undesired rotation, in one or both directions,related to physiological forces acting on the distal anchor, tetherand/or securing assembly. In other embodiments of the invention, thesecuring assembly may further comprise a reversibly engageable spoollock to resist undesirable spool rotation. Referring to the embodimentshown in FIGS. 61A to 61I, the spool lock 608 may comprise a four-sidedlocking flange 626 that prevents rotation of the spool 606 when thelocking flange 626 is positioned within a corresponding four-sidedlocking cavity 628 of the spool housing 616. In some embodiments of theinvention, the locking flange may also serve the function of a spoolflange. To rotate the spool 606 when desired, the four-sided lockingflange 626 may be displaced out of the four-sided locking cavity 628 ofthe spool housing 616, longitudinally along the rotation axis of thespool 606. Longitudinal displacement along the rotation axis of thespool 606 is provided because the cylindrical rotation surface 622 ofthe spool 606 has an axial length that is greater than the axial lengthof arcuate rotation surface or hole 624 of the spool housing 616. Thespool 606 may be biased to its locked position by a bias structure 630that applies an axial force on the spool to maintain or push thefour-sided locking flange 626 into the four-sided locking cavity 628 ofthe spool housing 616. This bias structure 630 may be a coil or leafspring, an elastically deformable wire or other similar structures knownin the art. The bias may be attached or retained in the spool housing inany of a variety of ways, including bonding, or retention within acavity 631, with or without a retaining plate 632, as illustrated inFIGS. 61A to 61I. To move the spool 606 from the locked position to theadjustment position, in the embodiment depicted in FIGS. 61H and 61I,the adjustment tool 621 is inserted into the spool adjustment interface620 with sufficient force to overcome the force exerted by the biasstructure 630.

In the specific embodiment of the invention shown in FIG. 61E, the spool606 may optionally comprise indentations, detents 634, or other surfacestructures that provide auditory and/or tactile feedback to the user ofthe adjustment tool 621. As the spool 606 is rotated, the interactionbetween the bias structure 630 and indentations 634 will cause aclicking that can convey to the user that the adjustment tool 621 isproperly inserted into the spool adjustment interface 620 and isproperly rotating.

Although one specific embodiment of the invention is depicted in FIGS.61A to 61I, one of skill in the art will understand that many lockingstructures or configurations may be used with a spool-based securingassembly. In another embodiment, the bias structure, such as aprotruding prong or tab, may be located on the spool itself near thespool adjustment interface and forms a mechanical interfit with acomplementary structure about the spool. When the adjustment tool isinserted into the spool adjustment interface, the bias structure isdisplaced from the complementary structure about the spool.Alternatively, the complementary structure, such as a groove or detent,may be located on the spool about the adjustment interface while thebias structure is located adjacent to the spool and projects into thecomplementary structure of the spool. In this alternate embodiment, whenthe adjustment tool is inserted into the spool adjustment interface, theprojecting bias structure is displaced form the complementary structureof the spool to allow rotation.

In still another embodiment, the spool is not axially displaceable butcomprises an interface with a lock assembly that resists spool rotationin at least one direction using a ratchet element. The ratchet elementor mechanical lock may be deactivated independently or as a result ofthe application of the spool adjustment tool. In another embodiment, thelock assembly may be a resistance lock provided by a rubber resistancepad. The position of the pad may be fixed or mobile.

Although the tether may be taken up or released from the spool directly,in other embodiments the securing assembly may comprise a lumen, ring orbushing to facilitate adjustment of the tether and/or to resist snaggingof the tether. FIG. 61B depicts a bushing 636 located on the posteriorregion of the securing assembly 600. When the curved surface 638 of thesecuring assembly 600 is attached in a typical fashion to the inferiorsurface of the mandible, the adjustment interface 620 of the spool 606will be positioned for access from the inferior chin surface while thebushing 636 will protect the tether as the tether passes in or out ofthe securing assembly 600.

The use of a spool or rotational assembly for the adjustment of thetether is generally preferred, because it allows a substantial range oftether adjustment in a limited amount of space. Other embodiments of amovable securing assembly that do not use rotational assemblies or arenot purely rotational, however, are also contemplated, including thosewith helical, slide or pivot assemblies for tether manipulation. Thesealternative mechanisms have a limited movement range compared to arotational assembly, but can be configured with a broader range ofadjustment by incorporating a ratchet and release subassembly with theslide or pivot assembly. One benefit of a movable securing assembly isthat it may allow the adjustment of an attached tether without the risksor complications associated with having to detach the tether in order toadjust it. Such risks may occur when using an eyelet or crimping-typesecuring device. Furthermore, the articulation or joint between themoving and non-moving components of the securing assembly are configuredto withstand the stress of repeated adjustment, in comparison to crimpstructures, which may fail with repeated crimp/uncrimp adjustmentprocedures.

FIGS. 61J and 61K depict one particular embodiment of the inventionwherein the distal anchor 500 and tether 28 are implanted into thetongue 9, either the base of the tongue or, preferably the anteriortongue. With the first and second ends (not shown) of the tether 28protruding from the inferior chin region after implantation, the firstand second ends of the tether are attached to the spool of the securingassembly. Excess tether length, if any, may be cut before, during orafter the attachment of the tether to the spool. Preferably, thesecuring assembly 600 is attached to its anchoring site, such as themandible 13, after the attachment of the tether 28, as this reduces thedegree of surgical exposure required to attach the tether 28 after thesecuring assembly 500 is attached to its anchoring site. In otherembodiments of the invention, attachment of the securing assembly to itsanchoring site prior to attachment of the tether, or even implantationof the distal anchor, may be desirable.

4. Delivery Systems

Referring to FIG. 62A to 62D, in a preferred embodiment of theinvention, the delivery system 711 for the distal anchor 500 comprises adelivery tool 700 with a tubular body 702, a pushrod 704 within thetubular body 702, a movable handle 708 for altering the relativeposition between the tubular body 702 and pushrod 704, and an optionalretraction assembly 710 for loading the implant into the tubular body.The delivery system 711 may optionally comprise an introducer 712dimensioned to allow insertion of the delivery tool 700 into its lumen714. The proximal end 716 of the introducer 712 may be provided with amechanical fit, such as a male Luer adapter 718, which can be attachedto the base 720 of the delivery tool 700 provided with a female Lueradapter 722, to lock the tubular body 702 to the introducer 712 andenhance the accuracy of inserting the distal tip of the delivery tool700 into the tissue. The delivery system 711 may also comprise a trocar724 for creating an insertion pathway from the skin insertion site tothe desired soft tissue site. The trocar 724 is preferably, but notnecessarily, dimensioned to also fit within the lumen 714 of theintroducer 712, such that the trocar 724 is insertable into the patienttogether with the introducer 712 and then removed from the introducer712 to allow placement of the delivery tool 700. The base 726 of thetrocar 724 may also be provided with a female Luer adapter 722 or othercomplementary interface to engage the introducer. In other embodiments,the locations of the male and female Luer adapters may be reversed, orother mechanical interfit configurations may be used.

In the particular embodiment of the invention illustrated in FIGS. 62Band 62C, the delivery tool 700 comprises a pushrod 702 attached to anactuator handle 708, the pushrod 702 having a distal position and aproximal position which can be manipulated by a user through theactuator handle 708. In an alternate embodiment, rather than moving thepushrod within the tubular body, the actuator handle is attached to amovable tubular to allow withdrawal of the overlying tubular body toexpose the distal anchor to the tissue, rather than pushing the distalanchor out of the delivery tube and into the tissue. The alternateembodiment may be advantageous in some instances because it maintains aconstant distal anchor position as the distal anchor is deployed, ratherthan pushing the distal anchor forward during deployment

Referring to FIGS. 62B and 62C, the distal anchor and tether may beloaded into the delivery tool by attaching the end(s) of the tether totether attachment site 727 on a spool 728 located within the deliverytool 700. When the tether is attached to the spool 728 and the dial 730attached to the spool 728 is rotated, the tether and distal anchor arepulled into the tubular body 702 as the tether is wound around the spool728. The proximal pulling of the distal anchor into the delivery tubecauses the expanded hook elements of the distal anchor to straighten andretract into their delivery profile and into the tubular body 702. Insome instances, rotation resistance is provided for the spool 728, forexample by using a biased resistance structure 732 with the retractionassembly 710. Rotational resistance may be useful to prevent inadvertentunspooling of a tether during packaging, storage or implantation of thedevice. FIGS. 62B and 62C depict one embodiment of the biased resistancestructure 732 comprising a cantilever 734 biased by a spring 736, thecantilever comprising a rubber grommet 738 or other resistance surfaceor structure

When the actuator handle 708 is moved from the loading position to thedeployed position, the actuator handle 708 overcomes the bias of theresistance structure to release the rotation resistance. This allows thespool 728 to freely rotate and to quickly deploy the distal anchor intothe tissue. As mentioned previously, the speed with which the distalanchor is deployed may affect the degree of tissue engagement by thedistal anchor. In some instances, it is desirable to reduce rotationresistance in the delivery phase compared to the loading phase of thedelivery tool usage.

To avoid inadvertent actuation or deployment of a distal anchor loadedinto the delivery tool, the actuator handle 708, spool 728, and/orpushrod 704 may be provided with a safety catch or pin that must firstbe manipulated before the one or more of these components can be moved.Referring to FIG. 62D, the actuator handle 708 has an indentation 740 orother configuration which can form a mechanical interfit with a movablepin 742 that can resist or prevent movement of the actuator handle 708when the pin 742. The movable pin 742 can be moved or slid between asafety position wherein a portion of the pin 742 interferes with themovement of the actuator handle 708, and a release position that removesthe mechanical interfit and allows movement of the actuator handle 708.

5. Soft Palate

As mentioned previously, the methods and devices described herein may beused to manipulate other body structures besides the tongue. Forexample, a tissue anchor may be implanted into the soft palate andattached to the hard palate using a tether. Referring to FIG. 63A, inone embodiment, the soft palate anchor 800 comprises one or moreexpandable hooks 802 that are preferably arranged in a generally planarconfiguration for insertion into the similarly planar-shaped soft palatetissue. A planar configuration reduces the risk that the tissue anchor800 forms a palpable nodule or protrudes from the superior or inferiorsurfaces of the soft palate. However, the expandable hooks 802 need notto lie in the same plane to have a generally planar configuration. Aplanar configuration may be characterized by an anchor having a maximumdimension as measured perpendicular to the longitudinal axis of theanchor that is greater than its orthogonal dimension also measuredperpendicular to the longitudinal axis. For example, FIGS. 63A and 63Billustrate two pairs of hooks 804, 806 that are stacked with the side byside of one pair 806 stacked against the side 814 of the other pair 804while still having a generally planar configuration. In otherembodiments, one pair may be nested within the inside surface of theother pair.

The soft palate anchor 800 may have a unibody design or may comprise amultiple components joined together. As illustrated in FIGS. 63A and63B, the soft palate anchor 800 may comprise a pair 804 of expandabledistal hooks 802 joined with a pair 806 of expandable proximal hooksusing a central core 808 and band 810.

The soft palate anchor 800 may be inserted into the soft palate using adelivery tool similar to that depicted in FIG. 62A. In otherembodiments, as shown in FIGS. 64A to 64D, the delivery tube 702, 816 ofthe delivery tool may be further configured to control the planarorientation of the tissue anchor 800, by a planar-configured deliverylumen 818. The planar-configured delivery lumen 818 may be achievedusing a unibody delivery tube 816, as depicted in FIG. 64A, or with oneor more additional delivery tube confining structures 820, as depictedin FIGS. 64B and 64C. The planar-configured delivery lumen 818 may beconcentrically or eccentrically located along the axis of the deliverytube 702, as illustrated in FIGS. 64B and 64C, respectively. Althoughthe cross-sectional shape of the delivery tube is typically differentfrom the cross-sectional shape of the delivery lumen in order tofacilitate rotation of the delivery tool during implantation, in otherembodiments, as shown in FIG. 64D, the cross sectional shape of both thedelivery lumen 818 and the delivery tube 826 may also has a planar outershape.

As shown in FIG. 65, the rotational position of the planar tissue anchormay also be controlled in the delivery lumen using a push rod 820 with adistal end 824 configured with a slot 822.

The soft palate anchor 800 may be inserted through the oral cavity 826,as shown in FIG. 66, or through the nasal cavity 828, as shown in FIG.67. Insertion of the soft palate anchor 800 may be facilitated bymanipulating the soft palate 4 to align it and the delivery tube 816.One of skill in the art will understand that any of a variety ofsurgical tools and techniques may be used to manipulate the soft palate4, including but not limited to forceps manipulation or the usetemporary sutures for applying traction to the soft palate 4. In otherembodiments, soft palate alignment structures or tools may be integratedinto the delivery tube 816. In still other embodiments, the deliverytube 816 may comprise a curved delivery tube to reduce the amount ofsoft palate manipulation. The curved delivery tube may comprise a curvedor flexible push rod with sufficient column strength to resist axialcompression when pushed distally.

FIGS. 68 and 69 depict further embodiments of the expandable soft palateanchor 800 system using different insertion and anchoring methods. FIG.68 depicts the tether 830 of the expandable soft palate anchor 800attached to the hard palate 8 by a fixation member 832, such as a boneanchor or screw. The tether 830 may also be optionally attached using anadjustment structure 834 that allows adjustment of tether tension orlength. These adjustment structures may include those depicted in FIGS.40A to 51E, and 61A, but are preferably configured with a reducedprofile to accommodate the anatomical limitations of the palate. Inanother embodiment, FIG. 69 depicts the tether 830 with a flat tissueanchor 800 at each end, with one anchor 800 in the soft palate 4 and theother anchor 800 attached to the mucosal tissue 836 overlying the hardpalate 8. This mucosal tissue 836 is less mobile than the soft palatetissue and therefore may also be used as an anchoring structure.Alternatively, a loop of suture may also be used to attach the softpalate anchor 800 to the mucosal tissue 836.

In some embodiments, as shown in FIG. 73A, the soft palate 4 may besuspended at a plurality of sites. For example, multiple anchors 900 maybe used to apply tension to four tissue areas 904 along the margin ofthe soft palate 4. The anchors 900 are preferably fixed to the hardpalate and/or lateral pharyngeal structures using an adjustmentassembly, but in other embodiments, one or more anchors 900 may beattached to a bone anchor or other bone fixation member. FIG. 73B isanother embodiment of the invention comprising two anchors 800 extendingfrom soft palate 4 to hard palate 8, which are used to suspend and raisethe mid-portion of the soft palate, resulting in enlarged spaces 916 inbetween tongue 9 and soft palate 4. In addition to the anchors 900described above, a variety of other tension structures may also be used,as would be understood by those skilled in the art.

In addition to anchoring soft palate tissue to the hard palate or otherless mobile tissue structures, the anchors 900 may be used to anchorsoft tissue to soft tissue, including two sites both in the soft palate,resulting in tissue compression between the two soft tissue sites. Thesoft tissue sites need not be located in the same anatomical structure.For example, tension may be formed between a soft palate tissue site anda tissue site of the pharyngeal arch.

In another embodiment, the soft palate 4 may be remodeled by deliveringa resilient member 908 to the soft palate 4 for creating tension incertain tissue areas 904. For example, in FIG. 74, an implant 908 with astraightening bias can be deployed within the soft palate 4 such that itcurves generally along the margin of soft palate 4. This causes thelateral tissue 904 of the soft palate 4 to stiffen and hold up byapplying compressive tension directed outwardly from the ends 912 of theresilient member 908. To reduce the risk of laceration or migration, theends 912 of the implant may be configured with a blunt end or otherstructure having an increased surface area. The implant 908 cancomprise, for example, shape memory metals such as Nitinol and any othermaterials with sufficient flexibility and stiffness, includingbioresorbable materials, that would apply tension to areas 904 asdesired and as will be understood by those skilled in the art.

In other embodiments, of the invention, the implant may have anon-linear configuration, such as a curved configuration, which may beimplanted by a similarly-curved applicator. In still other embodiments,the implant may have a non-linear, non-curved configuration that may bedelivered by an applicator having a different configuration. In suchembodiments, the applicator may be sufficiently large to accommodatedelivery of an implant having a different configuration, or the implantmay have sufficient resiliency so as to flex when loaded into a linearor curved applicator, while having sufficient stiffness to revert towardit original configuration when released from the applicator.

Although the resilient implant 908 may be inserted into the soft palate4 by conventional surgical means, in preferred embodiments the implantis dimensioned to fit within a hypodermic needle or other piercingdelivery tool 910. Referring to FIGS. 75A to 75F, beginning in a firstregion 902 of the soft palate 4, a delivery tool 910 is inserted along anon-linear pathway through the palate 4 to a second region 906 byreorienting the delivery tool 910 as it is inserted through the softpalate tissue. When the needle or delivery tool 910 is withdrawn todeposit the implant 908 along the pathway, the non-linear pathwaystraightens to adapt to the configuration of the more rigid linearmember 908. The degree of straightening will depend on the interplay ofelasticity of the linear body 908 and the compliance of the palatetissue.

In some embodiments, the resilient implant 908 may also be anchoredanteriorly to the hard palate 8, or laterally suspended to structures ofthe pharynx. Suspension or anchoring of the resilient implant 908 mayhelp to reduce counter-displacement of the uvula toward the tongue alongthe mid-portion of the implant 908 as the ends 912 of the implant 908compress the lateral palate tissue outwardly. The implant 908 may alsobe anchored or suspended in either a fixed or an adjustable manner.

In FIG. 76A, for example, the resilient implant 972 comprises anattaching element 976 for attaching the resilient implant 972 to thehard palate 8. Although the attaching element 976 depicted in FIG. 76Ais located along the midpoint of the implant 972, in other embodimentsthe attaching element 976 may be located anywhere along the implant 972.The attaching element 976 may comprise an aperture or other interfacefor fixing the implant 972 using a fixation member such as a bone screw.In other embodiments, the attaching element may be integral with theimplant 972, such as a barb, hook or other fixation structure. In theseembodiments, the implant 972 may be placed about the soft palate 4 andtissue surrounding the hard palate 8 using a delivery device orapplicator, and then the implant 972 subsequently attached to the hardpalate 8 or tissue surrounding the hard palate. In other embodiments,the delivery device or applicator may be used to pierce through the hardpalate or surrounding tissue during the implantation process. In suchembodiments, the attaching element 976 may be configured to sandwich thewall of the hard palate 8 or soft palate 4, similar to wall-anchorstructures known in the art.

In the specific embodiment depicted in FIG. 76A, the implant may furthercomprise paddle members 980 that increase the surface area of theimplant 972 to enhance the degree of shaping. The portions of theimplant 972 between the paddle members 980 and the attaching element 976may act as spring hinges 982 to provide lifting bias to the soft palate4. The paddles 980 and hinges 982 may be manipulated to adjust thetension applied by paddles 980 as desired depending on particularpatient needs. In some embodiments, tension adjustment of the implantmay occur by plastically deforming the implant 972, or by attachingrestraining elements to the hinge region, such as a tether with anadjustment assembly. The spring element feature of the implant 972stiffens and flattens soft palate 4, with a force bias 984 directedupwards and away from the tongue 9. The paddle members 980 may beintegrally formed or may comprise separate components. If separate, thepaddle members 980 may be contained in the same delivery tool orapplication for implantation in a single insertion step into the softpalate, or may be implanted in separate steps.

FIG. 76B illustrates the suspension of the soft palate 4 to themusculature or bony structures in the lateral walls 986 of the softpalate 4 using a anchoring element 1008 which extends across the palataltissue of the soft palate 4. The anchoring element 1008 comprisesmaterials that are capable of tensioning soft palate 4 as desired aswould be contemplated by those skilled in the art. The anchoring element1008 may also comprise a material or coating that stimulates fibrosis ortissue ingrowth about the anchoring element 1008 to reduce tissuecompliance. In some of these embodiments, the anchoring element 1008 mayfunction primarily as a tissue-engaging component and need not involvesignificant remodeling of the insertion pathway or biased configurationchanges to the implant, as described above. The anchoring element 1008may have a linear configuration as depicted in FIG. 76B, but one ofskill in the art will understand that other configurations may be used.For example, the resilient implant 908 depicted in FIGS. 74 and 75F maybe laterally suspended after insertion. The ends of the implant 908,1008 are attached and tensioned to lateral structures across thepharyngeal arch, without requiring a non-linear insertion pathway or abiased configuration. In still other embodiments, instead of suspendingthe anchor to a structure using a tether or a suture, the anchor mayhave one or more attaching structure for directly attaching the anchorto bone.

FIGS. 77A and 77B depict another embodiment of the remodeling implantcomprising a semi-rigid non-linear palate element 1010. The semi-rigidpalate element 1010 is configured to at least partially straightenwithin the lumen of a hypodermic needle or delivery tool 1012, yetregain at least some of its original configuration upon release from theneedle or tool 1012 such that the palate element 1010 is capable ofreconfiguring the soft palate 4 tissue upon return toward its originalnon-linear configuration. The palate element 416 may be made of a shapememory or superelastic material. A semi-rigid implant 1010 may beadvantageous in that it may be implantable into the palate with asimpler, single linear implantation pathway and linear applicator 1012,as shown, in FIG. 77A. Referring to FIG. 77B, upon release and regainingof its previous form, the palate element 1010 will cause a relativeredistribution of palatal tissue along the length of the palate element1010. To facilitate implantation of a semi-rigid implant 1010 into thesoft palate 4 so that the concavity of the palate element 1010 isoriented away from the tongue 9, the delivery tool 1012 may haverotational indicators to that allow the user to properly orient thepalate element 1010 with respect to the palate anatomy.

In some embodiments, the soft palate 4 can be suspended by everting itrelative to hard palate 8. Eversion as used herein is given its ordinaryand customary meaning, and is also used to refer to the redundantinfolding of the palate tissue onto itself, including but not limited tofolding the soft palate tissue over the hard palate tissue. As shown inFIGS. 78A to 78D, in one embodiment, one or more proximal surfaces 918,920 of the soft palate 4 can be everted or folded towards, over, and/orunder hard palate 8 and then fixed to hard palate 8. As shown in FIG.78A, in one embodiment, the two surfaces 918, 920 comprising theinferior and superior surfaces of soft palate 4 can be drawn towardscorresponding inferior and superior surfaces 8 a and 8 b of the hardpalate 8, with one end 920 pulled over hard palate 8 and one end 918pulled under hard palate 8. FIG. 78B shows the superior and inferiorpalatal surfaces 918, 920 positioned over and under hard palate 8 witheach surface 918, 920 fixed to hard palate 8 with one or more anchors800 and tethers 830. The relative angular relationship between the softpalate 4 and the hard palate 8 may be adjusted by altering the balancebetween the tensions of the superior and inferior tethers 830. Thetethers may be attached to any of a variety of fixation members 926 usedattach the anchors 800 to hard or soft structures, or may be attached toadjustment assemblies 832 as described above. Alternatively, sutures maybe used to attach the soft palate 4 and hard palate 8. FIG. 78C depictsanother embodiment wherein the soft palate surfaces 918, 920 arepositioned over and under hard palate 8 and fixed to each other with ananchor 922 traversing each surface 920 and a portion 924 of hard palate8 in between. Retaining members 930 of the anchor 922 resist separationof the palate tissue from the anchor 922. The retaining members 930 maybe fixedly attached or movably attached to the anchor 922. Although alinear fixation member is shown in FIG. 78C, in other embodiments acurved or angled fixation member may be used, and may be provided eitheras a rigid implant, a resilient implant or a flexible implant. FIG. 78Dshows another embodiment of the invention wherein the soft palate 4 isfolded onto only one side of the hard palate 8. In one preferredembodiment, the superior surface 920 of the soft palate 4 is foldedtowards and over the superior surface of the hard palate 8 via the nasalairway 928. In some of the above embodiments, the mucosa of the softpalate 4 and hard palate 8 are at least partially denuded to facilitateadhesion of the adjoining surfaces.

The anchors 900 used for the embodiments illustrated in FIGS. 73A, 73Band 78A to 78D can comprise a variety of structures, including thosementioned previously. Additional examples of anchors 900, as shown inFIG. 79A to 79E, include but are not limited to anchors 932 whichcomprise bone screws 936 at one end and tissues anchors 940 at the otherend (FIG. 79A), anchors 944 which comprise bone darts 948 at one end andtissue anchors 940 at the other end (FIG. 79B), and anchors 952comprising spring elements such as coils 960 (FIG. 79C), sinusoidmembers 964 (FIG. 79D), and elastic members 968 (FIG. 79E). The totallengths of the anchors 900 may vary. In some embodiments, anchors 900are less than or equal to about 3 cm. in length. FIG. 80 is a schematicfrontal view showing the soft palate 4 drawn towards hard palate 8 withspring loaded or adjustable anchors (not shown) engaging the soft tissueof the soft palate 4.

FIG. 81 depicts another embodiment of the invention, comprises a meshstructure 1014 implanted in the soft palate 4. Like the other softtissue implants described herein, the implant may also be suspended orsecured to another anatomical structure, such as the hard palate 8 oranother structure. In this embodiment, mesh structure 1014 has a flatconfiguration. In some embodiments, the mesh structure 1014 may beimplanted into the soft palate 4 in the flat configuration, but in otherembodiments, the mesh structure 1014 may be inserted into the softpalate as a curled or folded structure that is uncurled into a flat,deployed configuration. The mesh structure 1014, in one embodiment ofthe present invention, is deployed using a balloon dissection cannula(not shown) that passes from the inferior wall of the nasal cavity 928and into the tissue in soft palate 4. The balloon dissector createssufficient space in the soft palate for the mesh structure 1014 tounfurl.

6. Airway Reshaping

In some embodiments, the oral airway and/or the nasal airway can bereshaped to resist airway obstruction, without or without significantexpansion of airway cross-sectional area. For example, removal of tissuefrom or addition of materials to particular anatomical elements cancreate a permanent airway that maintains its integrity even duringtongue-based structural collapse against the hypopharynx, posteriorpharyngeal wall 12, and/or soft palate 4. Implants 988 can be deployedwithin tongue 9 and down at least a portion of the length of tongue 9starting at its base. For example, FIG. 82A shows implants 988 runningsuperior-inferior down tongue 9, creating a longitudinal groove 992between the implants 988. The formation of a collapse-resistant tonguegroove 992, alone or in combination with similar remodeling in the softpalate or posterior pharynx, may be used to maintain airway patency.FIG. 82B shows an embodiment comprising implants 988 placed within theposterior pharyngeal wall 12 anterior to the spine 996 to create areshaped airway. Stents 1000 or other expandable structures can also beimplanted within tongue 9 or posterior pharyngeal wall 12 to createdesired grooves within tongue 9 or posterior pharyngeal wall 12 forairway reshaping. FIG. 82C shows stents 1000 of a particular triangularshape implanted within the posterior pharyngeal wall 12. Stents of othershapes may also be used. The stents need not have a cylindrical shape,and in some embodiments, the size or cross-sectional shape of the stentmay vary along its length.

7. Recapture Systems

Although FIGS. 7G to 7J depict one embodiment for removing an implantedtongue anchor using a cannula, other embodiments of the inventionprovide additional features and structures to further facilitate removalof the implanted device.

Referring to FIGS. 70A to 70E, in another embodiment of the invention, arecapture tool 840 is provided when removal of the tissue anchor 800 isdesired. The recapture tool 840 comprises a recapture tube 842 with alongitudinal slot 844 at its distal end 846 and a handle housing 848 atits proximal end 850, a movable blocking assembly 852 and a movabletether guide 854 with a longitudinal slot 856. In the preferredembodiment, the blocking assembly 852 and tether guide 854 areconcentrically arranged inside the lumen 858 of the recapture tube 842,with the blocking assembly 852 between the tether guide 854 andrecapture tube 842. The longitudinal slots 844, 856 of the recapturetube 842 and tether guide 854 are aligned, with the tether guide 854preferably movable axially, but not rotationally, relative to therecapture tube 842. In one embodiment, axial mobility and rotationalalignment of the tether guide 854 is achieved by a longitudinalalignment groove 860 located at the proximal end 861 of the tether guide854 that interfaces with an alignment pin 862 inserting into the groove860 and held in place by the handle housing 848. The alignment pin 862may be further configured to allow locking and unlocking of the tetherguide 854 with respect to the recapture tube 842. This may be achievedby any of a variety of locking interfaces known in the art, includingbut not limited a rotational screw interface or a spring-biasedmechanical fit between the alignment pin and the groove.

The blocking assembly 852 typically comprises a tubular body 864 with akeyed longitudinal slot 866 at its distal end 868. Referring to FIG.70C, The keyed longitudinal slot 866 comprises a narrow slot 870 and ablocking surface 872 at its most distal end 868, and a wider slot 874just proximal to the narrow slot 870 and blocking surface 872. Theblocking assembly 852 has a proximal handle 876 to facilitate rotationof the blocking assembly 852 to open and closed positions within therecapture tube 842. The proximal handle 876 projects from an opening 878in the handle housing 848 of the recapture tube 842. In someembodiments; the opening 878 is configured to limit the range of motionof the proximal handle 876. Referring to FIG. 70D, in the open position,the narrow slot 870 of the blocking assembly 852 is generally alignedwith the longitudinal slots 844, 856 of the recapture tube 842 and thetether guide 854. This open position facilitates threading of theproximal end of a tether 830 of an implanted anchor 800 into therecapture tool 840. In the closed position, as shown in FIG. 70E, theblocking surface 872 of the blocking assembly 852 is located at thelongitudinal slot 844 of the recapture tube 842, effectively forming acircumferentially closed tube at the distal end 846 of the recapturetube 842. As described in greater detail below and depicted in FIG. 71H,as the implanted anchor 800 is pulled into the recapture tool 840, thecircumferentially closed distal end 846 of the recapture tube 842assures that the expanded members or hooks 802 of the implanted anchor800 are at least collapsed back to their unexpanded configuration andare not accidentally protruding from the longitudinal slot 844 of therecapture tube 842 in an expanded state as it is pulled into therecapture tube 842 and removed from the body. In the closed position,the wider slot 874 of the blocking assembly 852 remains in generalalignment with the proximal portions of the longitudinal slots 844, 856of the recapture tube 842 and the tether guide 854 so that the capturedtether 830 can still slide through the recapture tool 840.

Referring back to FIG. 70A, the tether guide 854 is configured to movelongitudinally within the recapture tube 842 and the blocking assembly852. The tether guide 854 further comprises a conical distal tip 880. Inits distal position, the tether guide 854 extends from the distal end846 of the recapture tube 842 and the conical tip 880 assists withseparating the tether 830 from the surrounding ingrown tissue, if any,as the recapture tool 840 is slid over the tether 830 towards the anchor800. In its distal position, the tether guide also facilitates thethreading of the tether 830 into the tether guide 854. Threading istypically accomplished using a needle hole threader that is well knownin the art and is inserted through the longitudinal slot 856 of thetether guide 854 and out of the tip lumen 882 of the conical tip 880.Once the tether 830 is engaged to the needle hole threader, it is pulledthrough the conical tip 880 and out through the longitudinal slot 856 ofthe tether guide 854.

In the proximal position, the tether guide 854 pulls the tether 830 moreproximally into the recapture tube 842 to allow the blocking assembly852 to rotate into its closed position without snagging the tether 830with the blocking surface 872. Once the blocking assembly 852 is movedto the closed position, the tether guide 854 may be repositioned back inthe distal position in order to allow the conical tip 880 to separatethe soft tissue from the tether 830 as the recapture tool 840 is guidedtoward the implanted anchor 800.

One embodiment for using the above recapture tool 840 comprisesachieving anesthesia of the midjaw and anterior tongue and accessing theproximal attachment site of the implanted device. Typically, anesthesiais achieved using local or regional anesthesia, but in other embodimentsof the invention, general anesthesia may be used. The proximal end ofthe tether 830 is released from its attachment site or adjustmentassembly and pulled out from the access site. A needle hole threaderinserted into the longitudinal slot 856 of the tether guide 854 and outof the lumen 882 of the conical tip 880. The proximal end of the tether830 can then be pulled into the conical tip 880 and out through thelongitudinal slot 856 of the tether guide 854, as depicted in FIG. 71A.In FIGS. 71B and 71C, the tether guide 854 is retracted into therecapture tube 842 to proximally shift the position where the tether 830exits the longitudinal slot 844 of the recapture tube 842. This allowsthe blocking assembly 852 to rotate into the closed position withoutsnagging the tether 830, thereby blocking the distal end 846 of therecapture tube's longitudinal slot 844 and forming a circumferentiallyclosed lumen, as shown in FIGS. 71D and 71E. In FIG. 71F, the tetherguide 854 is placed back in the extended position so the conical tip 880may be used to separate the soft tissue from the tether 830 as therecapture tool is passed over the tether 830 toward the implanted anchor800. Referring to FIG. 71G, the conical tip 880 is pushed distally untilit generally abuts the implanted anchor 800. As illustrated in FIG. 71H,tether position is maintained by pulling on the tether 830 as therecapture tube 842 is pushed distally against the implanted anchor 800,causing its expandable members 802 to curl or collapse back into astraighter configuration as it enters the recapture tube 842. Once theanchor 800 is retracted into the recapture tube 842, as illustrated inFIG. 71I, the entire recapture tool 840 may be withdrawn from thepatient. The existing bone anchor and/or adjustment assembly may beremoved or left in place, depending upon a variety of factors, such aswhether replacement anchors will be inserted and the functionality ofthe existing bone anchor and/or adjustment assembly.

In another embodiment of the recapture tool, shown in FIG. 72, thelongitudinal slot 844 of the recapture tube 842 does not fully extendthrough the distal end 846 of the recapture tube 842. In thisembodiment, the blocking assembly may be omitted and a distal segment884 of about 0.5 cm to about 2 cm or more of the recapture tube 842 iscircumferentially intact. To thread the exposed tether 830 into therecapture device 840, a needle hole threader is inserted through thelongitudinal slot 844 of the recapture tube 842 and tether guide 854until it is visible at the distal end of the recapture tube. The tetherguide is optionally retracted into the recapture tube 842 when theneedle hole threader is initially inserted and re-extended when the freeend of the tether 830 is pulled into the conical tip 880 of the tetherguide 854 and out through the slot 844 of the recapture tube 842. Theremaining recapturing steps are similar to the prior embodiment of therecapture system. Although this alternate embodiment of the recapturedevice omits the rotatable blocking assembly, it may be somewhat moredifficult to thread the tether into the device than with the otherembodiment.

One of skill in art the will also understand that the recapture tooldepicted in FIGS. 71A to 71G may be used or adapted to remove expandableanchors implanted elsewhere in the body, including but not limited tothe nasopharynx, soft palate, hard palate, pharyngeal wall, GI tract,bronchial tree, biliary tree, and genitourinary tract.

Although the delivery tool for implanting a planar-shaped tissue anchordepicted in FIG. 63A is preferably configured to control for rotation ofthe anchor during the implantation procedure, rotation control isgenerally unnecessary for a recapture of a planar anchor, but may beprovided in some embodiments.

D. Non-Anchored Tongue Remodeling

In one embodiment of the invention, the glossoplasty device is implantedin the tongue and does not require attachment or anchoring to any boneor other organ. One example of a non-anchored tongue remodeling deviceis the dual-anchor device described above and depicted in FIGS. 6A and6B. Other embodiments are described below.

1. Tongue Splinting

In one embodiment of the invention, a tongue splint is provided that iscapable of redistributing the mass of the tongue. The tongue splint maybe inserted to displace at least a portion of the base of the tongue orposterior tongue away from the posterior pharynx or pharyngopalatinearch to prevent or resist occlusion of the airway during sleep or otheractivities.

As shown in FIGS. 52E and 52F, in one embodiment of the invention, thetongue splint 404 comprises a rigid linear body 406 that is dimensionedto fit within a hypodermic needle or other piercing delivery tool 408.Referring to FIG. 52A, beginning on one side of the posterior tongue410, the delivery tool 408 is inserted in a general direction toward theposterior tongue 410 in a postero-medial direction, then, as shown inFIG. 52B, reoriented and advanced in an antero-medial direction untilgenerally the midline is reached. Referring to FIG. 52C, the needle ordelivery tool 408 is then reoriented and advanced in a postero-lateraldirection toward the opposite side of the tongue 9 before a finalreorientation and advancement in an antero-lateral direction.Advancement may be stopped at a submucosal location of the tongue 9, asillustrated in FIG. 52D, or may pierce the opposite side of the tongue9. One skilled in the art can determine the insertion pathway for therigid tongue splint 404 based upon the particular tongue 9 andoropharynx anatomy of a particular patient. In FIG. 52E, the needle ordelivery tool 408 is withdrawn to deposit the splint 404 along a pathwaythat redistributes the posterior mass 410 of the tongue 9 to reduceocclusion of the airway, as shown in FIG. 52F. In a further embodimentof the invention comprising the tongue splint 404, one or both ends 412,414 of the tongue splint 404 may project from the surface of the tongueand may be configured to engage a mouthpiece or appliance inserted intothe oral cavity to further displace the tongue mass.

FIGS. 53A and 53B depict another embodiment of the tongue splint 404comprising a semi-rigid non-linear tongue splint 416. The semi-rigidtongue splint 416 is configured to at least partially straighten withinthe lumen of a hypodermic needle or delivery tool 408, yet regain atleast some of its original configuration upon release from the needle ortool 408 such that the tongue splint 416 is capable of redistributingthe tongue mass upon return to its original configuration. The tonguesplint 416 may be made of a shape memory or superelastic material. Asemi-rigid implant 416 may be advantageous in that it may be implantableinto the tongue 9 with a single linear implantation pathway, as shown inFIG. 53A. Referring to FIG. 53B, upon release and regaining of itsprevious form, the tongue splint 416 will cause a relativeredistribution of tongue tissue. To facilitate implantation of asemi-rigid implant 416 into the tongue 9, the delivery tool 408 may haverotational indicators to that allow the physician to properly orient thetongue splint 416 with respect to the tongue anatomy.

2. Tongue Tissue Compression

In another embodiment of the invention, a glossoplasty device capable ofcompressing tongue tissue is provided. In one embodiment, illustrated inFIGS. 54A and 54B, the device comprises a variable pitch tissue screw418 having a distal end 420 with a long pitch, a middle section 422 witha shorter pitch, and a proximal head 424 configured to engage anddisengage a rotational tool 426 for driving the tissue screw 418 intothe tongue 9. The tissue screw 418 is configured to pierce and advancethrough soft tissue. As the tissue screw 418 advances, the distal end420 with the long pitch defines a spiral pathway through the tissue witha first tissue volume 428 between turns of the spiral pathway. As theshorter pitch portions 422 of the tissue screw 418 are advanced throughthe pathway defined by the distal end 420, the middle section 422 of thetissue screw 418 will compress the first tissue volume 428 defined bythe long pitch distal end 420 into a smaller second volume 430 caused byredefined by the shorter pitched portions 422 of the tissue screw 418.Compression of the tongue tissue along the tissue screw 418 willgenerally bias or displace the tongue tissue toward the insertion siteof the tissue screw 418, and may indirectly bias or displace the base ofthe tongue 9 or posterior tongue 410 from the posterior pharynx orpharyngopalatine arch. The compression and displacement of tongue tissueby the variable pitch tissue screw 418 may be further augmented byattaching the proximal head 424 or other portion of the tissue screw toa fixed or variable length tether and attaching tether to anotherstructure such as the mandible 13 or hyoid bone 15.

In one embodiment of the invention, shown in FIGS. 55A and 55B, theglossoplasty device comprises a spring or coil 432 that is advanced intothe tongue tissue in a first configuration having a long pitch w′, andthen changed to a second configuration with a shorter pitch w″, therebycompressing the tongue tissue about or between the turns of the springor coil 432. In one embodiment, the coil 432 has a sufficient stiffnessto be advanced into the tongue tissue in its first configuration similarto that of the tissue screw previously described. If the springcomprises a shape memory material such as Nitinol, the spring is able toassume the second configuration with a shorter pitch w″ upon warming upto body temperature and/or elastic recoil, thereby compressing thetongue tissue. In another embodiment of the invention, the distal tip434 of the coil 432 is attached to a suture or wire that is firstinserted into the tongue 9 along the desired insertion path. Tension isapplied to the suture or wire to maintain the coil 432 in its firstposition as it is advanced into the tongue 9. Once the spring ispositioned, the suture tension is released to allow the coil 432 toassume its second configuration to engage and compress the tonguetissue. The suture or wire may be cut to eliminate any exposed foreignbody and to reduce the risk of infection tracking down the suture path.

In some instances, the change in configuration from the firstconfiguration to the second configuration may not cause tissuecompression because the coil 432 failed to engage the surroundingtissue. In such situations, the coil 432 may axially contract andradially expand to form a cavity without any tissue between the spirals.As shown in FIG. 56, to reduce the risk of non-engagement of the tonguetissue, the coil 432 may be configured with a series of barbs, hooks,angled pins or other tissue engaging structures 436 to facilitateengagement and compression of the tissue as the coil 432 assumes thesecond configuration. The location, spacing, orientation and length ofthe tissue engaging structures 430 may be determined by one skilled inthe art with routine experimentation. The characteristics of each tissueengaging structure 436 need not be uniform along the length of the coil432. For example, the tissue engaging structures at the proximal anddistal ends of the coil 432 may be configured differently than theengaging structures 436 in the middle portion of the coil 432 becauserather than compress the tongue tissue, the ends 434, 438 of the springmay be configured to attach and pull the surrounding tissue towards themiddle section of the coil 432. To facilitate insertion of a spring orcoil 432 comprising tissue engagement structures 436, the spring or coil432 may be covered with a sheath during the insertion process to reducethe risk of engaging tissue prior to final positioning of the device.The sheath can be removed to expose the tissue engaging structures 436upon final positioning.

In another embodiment of the invention, the spring or coil 432 may beinserted in its first configuration within the lumen of a needle orother delivery device. In some instances, however, reducing the diameterof the spring or coil 432 sufficiently to fit within a lumen device maycause plastic deformation of the spring or coil 432 such that the springor coil lack the elastic properties to assume the second configuration.Alternatively, as shown in FIG. 57, the spring or coil 432 may be placedaround the outer surface 440 of a needle or other piercing device 442for insertion into the tongue 9. In a further embodiment, illustrated inFIG. 58, the needle or other piercing device 442 may comprise a fittedspiral groove 444 or tract along the outer surface 440 to reduce or makeflush the profile of the spring or coil 432 on the delivery device 442.FIGS. 59A and 59B depict the implantation of the coil-on-needle device432, 442. FIG. 59A depicts the positioning the distal end 434 of thecoil 432 prior to the complete release of the implant from the sheath446, while FIG. 59B schematically illustrates the resulting tissuecompression from the released coil 432.

3. Tongue Tissue Compliance Change

In another embodiment of the invention, the tongue remodeling systemchanges the compliance of the tongue tissue surrounding the implanteddevice, but does not require exertion of a continuous force upon thesurrounding tongue tissue. In some instances, a change in the tissuecompliance without placing the tissue under compression may besufficient to reduce or eliminate airway occlusion during apneaepisodes. The implantation of the device without creating tissuecompression may simplify the implantation procedure by eliminating theneed to adjust the degree of tissue tension exerted by the device eitherduring or after the initial implantation procedure. Many of theembodiments of the invention mentioned previously may be used withoutaltering the physical characteristics of the tether and/or splint byimplanting the device and not exerting tension on the device during theimplantation process Thus, although the device exerts reduced or noforce while the tongue is in usual or resting position, but when thepatient is asleep and the musculature of the oropharynx and/orhypopharynx relaxes, the compliance of the tongue tissue altered by thedevice such that greater force is required to cause posteriordisplacement of the tongue. One skilled in the art may also select thematerials and/or configurations of the tether and/or splint for thepreviously disclosed embodiments to modify the degree of change intissue compliance.

E. Materials

The materials that may be used to construct the tether component of theglossoplasty device were discussed previously. The other components ofthe invention, such as the distal anchor and/or securing assembly, maybe manufactured in accordance with any of a variety of techniques whichare well known in the art, using any of a variety of medical-gradeconstruction materials. One or more components can be molded, formed ormachined from biocompatible metals such as Nitinol, stainless steel,titanium, and others known in the art. One or more components can alsobe injection-molded from a variety of medical-grade polymers includinghigh or other density polyethylene, nylon and polypropylene. Portions ofthe system can be separately formed and secured thereto in apost-molding operation, using any of a variety of securing techniquessuch as solvent bonding, thermal bonding, adhesives, interference fits,pivotable pin and aperture relationships, and others known in the art.

Reinforcing fibers suitable for use in the components of the presentinvention include ceramic fibers, like bioabsorbable hydroxyapatite orbioactive glass fibers. Such bioabsorbable, ceramic fiber reinforcedmaterials are described, e.g., in published European Patent ApplicationNo. 0146398 and in WO/96/21628, the entire disclosures of which areincorporated herein by way of this reference. The materials may alsoinclude a bioabsorbable coating previously described.

As a general feature of the orientation, fiber-reinforcement orself-reinforcement of the tongue remodeling components, many of thereinforcing elements may be oriented in such a way that they can earlyeffectively the different external loads (such as tensile, bending andshear loads) that are directed to the remodeling system as used.

The components of the invention (or a bioabsorbable polymeric coatinglayer on part or all of the implant surface), may contain one or morebioactive substances, such as antibiotics, chemotherapeutic substances,angiogenic growth factors, substances for accelerating the healing ofthe wound, growth hormones, antithrombogenic agents, bone growthaccelerators or agents, and the like. Such bioactive implants may bedesirable because they contribute to the healing of the injury inaddition to providing mechanical support.

In one embodiment, the distal anchor may comprise a bioabsorbablecoating and/or structure. As used herein, terms such as bioabsorbable,bioresorbable and biodegradable interchangeably refer to materials whichwill dissipate in situ, following a sufficient post-operative period oftime, leaving acceptable byproducts. A variety of polymers which may beuseful for the components of the present invention are identified below.Many of these polymers have been reported to be biodegradable intowater-soluble, non-toxic materials which can be eliminated by the body:polycaprolactone, poly (L-lactide), poly (DL-lactide), polyglycolide,poly (L-Lactide-co-D, L-Lactide), 70:30 poly (L-Lactide-co-D,L-Lactide), 95:5 poly (DL-lactide-co-glycolide), 90:10 poly(DL-lactide-co-glycolide), 85:15 poly (DL-lactide-co-glycolide), 75:25poly (DL-lactide-co-glycolide), 50:50 poly (DL-lactide-co-glycolide),90:10 Poly (DL-lactide-co-caprolactone), 75:25 poly(DL-lactide-co-caprolactone), 50:50 poly (DL-lactide-co-caprolactone),polydioxanone, polyesteramides, copolyoxalates, polycarbonates, and poly(glutamic-co-leucine). The desirability of any one or a blend of theseor other polymers can be determined through routine experimentation byone of skill in the art, taking into account the mechanicalrequirements, preferred manufacturing techniques, and desiredreabsorption time. Optimization can be accomplished through routineexperimentation in view of the disclosure herein. Bodily reaction to thebioabsorbable materials or byproducts may furnish at least a portion ofthe support provided by the device or treatment method. All or portionsof any of the devices herein, as may be appropriate for the particulardesign, may be made from allograft material, or synthetic bone material.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

What is claimed is:
 1. A method for treating a patient with an airwaydisorder, comprising: providing a palate remodeling system, the systemcomprising a first fixation member and a first palate element, the firstpalate element comprising a tissue anchor and a tether; inserting thetissue anchor into a soft palate of a patient; attaching the tether ofthe first palate element to the first tether support; folding a firstsurface of the soft palate toward a first surface of the hard palate;and fixing the first fixation member with respect to the hard palate. 2.The method for treating a patient with an airway disorder as in claim 1,wherein the palate remodeling system comprises a second palate element.3. The method for treating a patient with an airway disorder as in claim2, wherein the palate remodeling system comprises a second fixationmember.
 4. The method for treating a patient with an airway disorder asin claim 1, wherein fixing the first fixation member with respect to thehard palate comprises fixing the first tether support to mucosal tissueoverlying the hard palate.
 5. The method for treating a patient with anairway disorder as in claim 1, wherein fixing the first fixation memberis performed before attaching the tether to the first tether support. 6.The method for treating a patient with an airway disorder as in claim 1,wherein the tissue anchor is an expandable tissue anchor.
 7. The methodfor treating a patient with an airway disorder as in claim 1, whereinthe tissue anchor and the tether are pre-attached.
 8. The method fortreating a patient with an airway disorder as in claim 1, wherein thefirst fixation member is an adjustable tether support.
 9. The method fortreating a patient with an airway disorder as in claim 1, furthercomprising folding a second surface of the soft palate toward a secondsurface of the hard palate, wherein the first surface of the hard palateis a superior surface and the second surface of the hard palate is aninferior surface.